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Remote Regulatory Affairs Manager - Global Submissions Lead
Crinetics Pharmaceuticals, Inc. 3.9
Remote regulatory compliance manager job
A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance.
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$85k-126k yearly est. 1d ago
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Regulatory Manager
Precision Medicine Group 4.1
Remote regulatory compliance manager job
The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
Essential functions of the job include but are not limited to:
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings
Qualifications:
Minimum Required:
Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
Computer literacy (MS Office/ Office 365)
Fluent in English
Preferred:
Graduate, postgraduate
Possesses basic understanding of financial management
Other Required:
5 + years or more relevant regulatory affairs experience
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays
Competencies
Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
Motivates other members of the project team to meet timelines and project goals
Flexible attitude with respect to work assignments, and new learning
Resolves project related problems and prioritize workload to meet deadlines with little support from management
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Collects data of consistently high standard
Communicates both verbally and in written form in an acceptable manner
Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
#LI-Remote
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$106,000-$151,000 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
$106k-151k yearly Auto-Apply 3d ago
US Regulatory Compliance Manager
Blockchain.com 4.1
Remote regulatory compliance manager job
Blockchain.com is connecting the world to the future of finance. As the most trusted and fastest-growing global crypto company, it helps millions of people worldwide safely access cryptocurrency. Since its inception in 2011, Blockchain.com has earned the trust of over 90 million wallet holders and more than 40 million verified users, facilitating over $1 trillion in crypto transactions.
As the US Regulatory ComplianceManager, you will be the architect and leader of our US regulatory strategy. This is a cornerstone position responsible for navigating the complex federal and state regulatory landscape to enable our continued growth and innovation. You will own the company's licensing roadmap, serve as the primary relationship manager with regulators, and provide strategic guidance that embeds compliance into the fabric of our products and operations. Your work will be critical to securing the company's long-term success and trustworthiness in the market.
WHAT YOU WILL DO
Regulatory Strategy & Leadership: Develop, implement, and manage the company's comprehensive US regulatory compliance program.
Licensing Execution: Spearhead the company's state-by-state licensing strategy, with a primary focus on obtaining and maintaining Money Transmitter Licenses (MTLs). This includes managing applications, renewals, surety bonds, and required reporting across all relevant jurisdictions.
Regulatory Engagement: Serve as the primary point of contact and cultivate strong, proactive relationships with federal and state regulators, including FinCEN, OCC, and state banking departments. Manage all regulatory examinations, inquiries, and correspondence.
Product Compliance Advisory: Partner directly with Product, Engineering, and Business leadership to provide proactive regulatory guidance on new products and initiatives. Ensure a “compliance-by-design” approach, translating complex regulatory requirements into actionable product specifications.
Reporting: Provide regular, clear reporting on the status of the compliance program, risk exposure, and key regulatory developments to the executive team.
WHAT YOU WILL NEED
7 years of regulatory compliance experience within the financial services or fintech industry.
Demonstrated, hands-on experience with the US Money Transmitter Licensing (MTL) framework, including application, maintenance, and reporting processes.
Deep subject matter expertise in BSA/AML, KYC/CIP, and OFAC sanctions programs.
Proven ability to interpret and apply complex financial regulations to innovative products and business models.
What we'd love to see (Preferred Qualifications):
Juris Doctor (J.D.) or a relevant advanced degree (e.g., MBA).
Direct experience with cryptocurrency or digital asset compliance programs.
Experience in a high-growth technology company environment.
Established relationships and direct interaction experience with key state and federal financial regulators.
Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or CRCM (Certified Regulatory ComplianceManager).
COMPENSATION & PERKS
Competitive full-time salary based on experience and meaningful equity in an industry-leading company
This is a role based in our Dallas office, with a mandatory in-office presence four days per week.
The opportunity to be a key player and build your career at a rapidly expanding, global technology company in an exciting, emerging industry.
Performance-based bonuses
Apple equipment provided by the company
Work from Anywhere Policy: You can work remotely from anywhere in the world for up to 20 days per year.
Blockchain is committed to diversity and inclusion in the workplace and is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, religion, color, national origin, gender, gender expression, sex, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, and apprenticeship. Blockchain makes hiring decisions based solely on qualifications, merit, and business needs at the time.
You may contact our Data Protection Officer by email at ******************. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.
$79k-126k yearly est. Auto-Apply 32d ago
EMI Regulatory Compliance Manager
Moneycorp
Remote regulatory compliance manager job
at Moneycorp
Welcome to Moneycorp We're delighted you're interested in being a part of Moneycorp. In the last decade, Moneycorp has transformed from a largely domestic, consumer-focused provider of foreign exchange to an end-to-end global payments' ecosystem. With two banking licenses and operations across the entire value chain of the international payments and foreign exchange sectors, we enable businesses, institutions, and individuals to thrive beyond borders. We help our clients realise their growth ambitions by providing them with worldwide reach, relentless regulatory excellence, and tailored, relevant solutions that resiliently optimise their financial operations. We're fervent about pursuing our goals, making substantial contributions to the payments industry, and consistently offering unwavering support to our clients at every stage of their journey. Moneycorp is a place where energy, commitment to our shared success and collaboration are core to our DNA. We're restless in our drive to surpass the expectations of our clients and unlock opportunities to support them at every stage of their journey. The foundation of our success is our people, and nurturing a culture of belonging for all of our colleagues is central to our journey as a global business. Find out more about Moneycorp's offering, global footprint and capabilities here: About Us | moneycorp Who You Are / Your Next Challenge Moneycorp in Dublin have an exciting opportunity for an EMI (Electronic Money Institution) Regulatory ComplianceManager. The successful candidate will be responsible for supporting the Head of Compliance to ensure effective compliance frameworks are in place which aims to ensure compliance with regulatory requirements and with the conditions of the firm's regulatory authorisations. What we're looking for / Skills that will help you in the role Critical experience required:
Experience working in payments/electronic money regulated firms
Extensive knowledge and understanding of the applicable EU and CBI regulations
Experience/knowledge of outsourcing and operational resilience regulations is required
Knowledge and/or experience of DORA would be advantageous
Critical skills required:
Strong management skills
Excellent communication skills, both written and oral
Demonstrable track record in regulatory relationship management and compliance framework development
Organisational and prioritisation skills
Hard working, conscientious and trustworthy
Accepts accountability for delivering results against deadlines
Problem solver
This position is full-time, permanent. The role is expected to be office-based in Dublin, Ireland. What you get in return:This role offers a competitive salary with bonus, plus a comprehensive benefits package. Interested?If the role sounds like you, we invite you to upload a copy of your CV by clicking on the Apply button. Start Date: ASAP Fostering a culture of belonging and inclusivity We're committed to creating a workplace where every individual feels valued, respected, and included. As an Equal Opportunity Employer, we actively cultivate an inclusive culture where diversity thrives, and we empower our colleagues to drive meaningful change within our organisation through initiatives like our DE&I focus groups and value champion network. Like many of our peers, we recognise that fostering inclusivity is an ongoing journey, and we remain steadfast in our commitment to progress. By measuring our efforts through regular assessments and listening to the feedback of our employees, we strive to ensure that our initiatives are impactful and responsive to the evolving needs of our workforce.Together, we want to build a workplace where everyone can bring their authentic selves to work, as we believe this is the foundation of innovation, creativity, and collective success. Connect with us For company news, announcements and market insights, visit our News Hub. You can also find Moneycorp on Facebook, Twitter UK, Twitter Americas, Instagram, LinkedIn, where you can discover how we are leading the way in global payments and currency risk management.
Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally.
The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams.
This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings.
Key Responsibilities
Interface with federal, province, and state agencies on regulatory policy and compliance.
Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC.
Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses
Submit all safety related reports to federal, province, and state agencies.
Manage safety recall process for US and Canada.
Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC.
Review Owner's manual & Warranty Books.
Approve Safety, Emissions, and other Homologation Labels for each model year.
Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC.
Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases)
Validate certification applications and fleet reporting for submission to agencies
In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders
Troubleshooting and escalation for certification & campaigns
Assess Regulation to provide recommendations for portfolio, product & development planning
Explore opportunities for exemptions, derogations, optimization of phase-in plans
Support Maserati commercial & marketing teams in product communication & dealer training
Support Maserati SCM on compliance implications linked to product labeling and logistic flows
Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB.
Prepare and present the annual emissions certification preview to EPA and CARB.
Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents
Manage activities relating to emissions related parts and defect reporting
Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC
Prepare and submit required importation documents for Canada.
$83k-127k yearly est. 10h ago
Member of Compliance, Transaction Monitoring
Anchorage Digital
Remote regulatory compliance manager job
At Anchorage Digital, we are building the world's most advanced digital asset platform for institutions to participate in crypto. Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance, settlement, and the industry's leading security infrastructure. Home to Anchorage Digital Bank N.A., the first federally chartered crypto bank in the U.S., Anchorage Digital also serves institutions through Anchorage Digital Singapore, Porto by Anchorage Digital, and other offerings.
The company is funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion. Founded in 2017 in San Francisco, California, Anchorage Digital has offices in New York, New York; Porto, Portugal; Singapore; and Sioux Falls, South Dakota. Learn more at anchorage.com, on X @Anchorage, and on LinkedIn.
We're building something truly unique here at Anchorage Digital. As the only federally chartered digital asset bank in the United States, we sit at the intersection of traditional banking and the rapidly evolving world of digital assets. Our transaction monitoring team plays a critical role in that mission: protecting the integrity of the financial system while supporting innovation in a space that's redefining how money moves.
Joining our team means being part of a first-of-its-kind institution where your work will directly shape the standards for compliance and risk management in digital finance. You'll collaborate with experts across banking, technology, and crypto to design and refine monitoring strategies that go beyond the playbook of traditional financial institutions. Every decision you help make has real impact. Not just for our clients, but for the broader industry.
If you're looking for an opportunity to be on the cutting edge, to bring creativity and rigor to solving complex problems, and to help set the tone for how digital assets and banking coexist responsibly, this is the place to do it. We're not just monitoring transactions. We're helping write the future of finance Technical Skills:
Demonstrates extensive knowledge and experience with the tools used by the transaction monitoring team, and is able to speak to them at a high level with senior management.
Demonstrates experience in identifying gaps in team workflows and procedures, raising awareness to leadership with suggestions on how to properly address the gaps and ensure proper procedures are followed, updated, and training conducted within and outside of the team, as appropriate.
Complexity and Impact of Work:
Provide feedback to direct leadership on methods or systems used by the team, or outside of the team, having the ability to navigate roadblocks and obstacles that may come up, and escalating when blocked.
Manage transaction monitoring alerts and disposition workflows.
Ability to work independently with good time management skills, managing multiple tasks assigned with little to no direction, only requiring work to be reviewed at critical points.
Ability to conduct Quality Assurance/Quality Check reviews of L1 Analyst reviews.
Assist the team in tuning exercises, as well as implementation of monitoring rules to prevent and detect money laundering, fraud or other financial crime responding to emerging trends.
Is a prolific contributor of high quality who makes impactful contributions to the team, and identifies opportunities for improvement.
Consistently demonstrates on-time delivery and high quality work product. Where a deadline or commitment is at risk, escalates to manager to help manage priorities, if appropriate, and alerts affected stakeholders so "no surprises."
Organizational Knowledge:
Is aware of the strategy of Anchorage Digital to guarantee its successful implementation and is considered when defining the planning and goals of the team.
Has a deep understanding of the team's objectives and works with leadership to ensure regulatory compliance is being met.
Ensures that knowledge is shared amongst the transaction monitoring team and does not position themselves or others as a single point of failure.
Communication and Influence:
Promotes positive working environments for inside and outside of the team with proper listening, speaking and empathy with colleagues, as well as embodies as a role model of our culture pillars.
Works closely with the team in order to solve problems and assist or guide other members in processes or workflows within their area of specialization or domain, helping others understand the strategic goals of Anchorage and how their work relates to these.
Uses expert judgment, insight, recommendations, conclusion, and ideas on how to improve the team (e.g., workflows, inventory, etc.)
Consistently expresses clear, thoughtful, analytical and solutions-oriented communications, whether in high-impact slides/decks, written communications in slack or email, or verbal communications.
You may be a fit for this role if you have:
Experience in BSA/AML transactional review for institutional and retail clients
Knowledge in BSA/AML and/or Sanctions regulations + Fraud Typologies
Expertise in using blockchain analytics tools to disposition transaction monitoring alerts, preferably at a Bank or regulated Exchange
A passion for building out programs in their early stages, including creation and maintenance of policies, procedures, and new tools
A proven track record of being able to work independently
A strong attention to detail
Highly curious and a fast learner
Although not a requirement, bonus points if:
You were emotionally moved by the soundtrack to Hamilton, which chronicles the founding of a new financial system. :)
You have expertise in data analytics and/or spreadsheet pivots/formulas for data analysis
Blockchain Analytics Certifications (TRM, Chainalysis, etc.)
Fraud Certifications
About Anchorage Digital: Who we are
The Anchorage Village, what we call our team, brings together the brightest minds from platform security, financial services, and distributed ledger technology to provide the building blocks that empower institutions to safely participate in the evolving digital asset ecosystem. As a diverse team of more than 600 members, we are united in one common goal: building the future of finance by providing the foundation upon which value moves safely in the new global economy.
Anchorage Digital is committed to being a welcoming and inclusive workplace for everyone, and we are intentional about making sure people feel respected, supported, and connected at work-regardless of who you are or where you come from. We value and celebrate our differences and we believe being open about who we are allows us to do the best work of our lives. Anchorage Digital is an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. Anchorage Digital considers qualified applicants regardless of criminal histories, consistent with other legal requirements. “Anchorage Digital” refers to services that are offered either through Anchorage Digital Bank National Association, an OCC-chartered national trust bank, or Anchorage Lending CA, LLC a finance lender licensed by the California Department of Financial Protection and Innovation, License No. 60DBO-11976, or Anchorage Digital Singapore Pte Ltd, a Singapore private limited company, all wholly-owned subsidiaries of Anchor Labs, Inc., a Delaware corporation.
Protecting your privacy rights is important to Anchorage Digital, and we work to maintain the trust and confidence of our clients when handling personal or financial information. Please see our privacy policy notices here.
Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally.
The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams.
This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings.
Key Responsibilities
Interface with federal, province, and state agencies on regulatory policy and compliance.
Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC.
Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses
Submit all safety related reports to federal, province, and state agencies.
Manage safety recall process for US and Canada.
Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC.
Review Owner's manual & Warranty Books.
Approve Safety, Emissions, and other Homologation Labels for each model year.
Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC.
Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases)
Validate certification applications and fleet reporting for submission to agencies
In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders
Troubleshooting and escalation for certification & campaigns
Assess Regulation to provide recommendations for portfolio, product & development planning
Explore opportunities for exemptions, derogations, optimization of phase-in plans
Support Maserati commercial & marketing teams in product communication & dealer training
Support Maserati SCM on compliance implications linked to product labeling and logistic flows
Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB.
Prepare and present the annual emissions certification preview to EPA and CARB.
Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents
Manage activities relating to emissions related parts and defect reporting
Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC
Prepare and submit required importation documents for Canada.
$88k-140k yearly est. 10h ago
Director, Ethics and Compliance
Henry Schein 4.8
Remote regulatory compliance manager job
The Director, Ethics & Compliance position will report to the Chief Ethics & Compliance Officer and will be primarily responsible for overseeing and improving the Ethics & Compliance program for the Henry Schein Products Group (HSPG). The Director, Ethics & Compliance will provide advice and counsel on compliance with various legal and regulatory requirements applicable to the manufacturing, sales & marketing operations of HSPG globally and will provide advice on and support for the strategic plan.
The Director, Ethics & Compliance, will collaborate with internal clients at all levels of management as well as the corporate Ethics & Compliance team; the role requires the ability to work confidently, proactively, and assertively with a high level of independence. The position requires an individual who can work in new subject matter areas on a daily basis and who can assimilate information quickly and develop expertise in those areas.
Duties include providing counseling on healthcare compliance issues; working closely with the Chief Ethics & Compliance Officer and the Henry Schein Ethics & Compliance team on strategic compliance matters; providing support on the general compliance needs of the HSPG business unit ; collaborating with key stakeholders to develop, review and/or deliver compliance learning and communications for internal and external audiences; developing and executing auditing and monitoring plans; supporting remediation and risk mitigation efforts, conducting or supporting internal investigations (as needed).
KEY RESPONSIBILITIES:
Oversee and evolve the ethics & compliance function and collaborate with key stakeholders to ensure compliance with applicable laws and regulations covering topics such as anti-kickback statute, global anti-bribery/anti-corruption (ABAC), antitrust, data protection and privacy, conflicts of interest, transparency, interactions with healthcare professionals and entities including fee-for-service engagements, third party risk management, advertising and promotion of medical devices, sponsorships, grants, donations, samples.
Collaborate with Commercial team members to create solutions for developing and maintaining compliant relationships with healthcare professionals and government officials
Provide compliance training on a wide range of issues including Worldwide Business Standards (our code of conduct), interactions with healthcare professionals, conflicts of interest, ABAC, labeling and promotional content
Together with the Chief Ethics & Compliance Officer and other key stakeholders, develop and implement a monitoring and auditing program designed to ensure compliance with internal policies and procedures and applicable laws, regulations and industry guidance and standards
Review new product offerings to ensure compliance with applicable policies and procedures and laws
Manage outside counsel as necessary
Support the implementation of the ethics & compliance risk assessment and mitigation actions as well as monthly compliance reports and executive risk dashboard
Ensure applicable annual transparency reporting requirements are met (state, federal and international)
Interpret and disseminate information on regulatory and compliance matters
Assist with internal investigations, business partner and government inquiries and actions, and related responses and resolution
Enhance corporate compliance and organization reputation by accepting ownership for accomplishing new and different requests, providing prompt and accurate advice and appropriate solution recommendations, and identifying continuous improvement opportunities
Perform other duties as assigned or as necessity dictates
SPECIFIC KNOWLEDGE & SKILLS:
Experience with healthcare law compliance for a global medical device manufacturer (orthopedic medical devices a plus) and experience leading a team or key initiatives
Strong knowledge of HHS-OIG's Compliance Program Guidance for Pharmaceutical Manufacturers (including 7+ elements of an effective compliance program), AdvaMed Code, DOJ's Evaluation of Corporate Compliance Programs (September 2024), False Claims Act, Anti-kickback Statute, anti-bribery/anti-corruption laws (e.g., FCPA, UK Bribery Act), data protection laws (e.g., GDPR, CCPA), Sunshine Act and other transparency laws.
Experience working with Commercial teams
Strong understanding of compliance controls, processes and activities common to the medical device industry
Strong understanding of healthcare compliance and enforcement environment
Bilingual (English/Spanish) required
GENERAL SKILLS & COMPETENCIES:
Broad and unique range of professional skills with an expert understanding of industry practices
Outstanding proficiency with tools, systems, and procedures
Expert planning/organizational skills and techniques
Expert independent decision making, analysis and problem solving skills
Outstanding verbal and written communication skills
Outstanding presentation and public speaking skills
Outstanding interpersonal skills
Outstanding conflict resolution skills and ability to deliver difficult messages
Use skill and influence to develop company objectives and principles and to achieve goals in creative and effective ways
Excellent negotiating skills
Strategic planning skills
Project management, consultative skills and ability to manage a budget
Expert in multiple technical and/or business skills
Ability to cultivate and develop lasting internal and external customer relations
Recognized in the industry as an expert
Strong financial skills
MINIMUM WORK EXPERIENCE:
Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience.
PREFERRED EDUCATION:
Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent preferred. May hold two or more industry certifications.
TRAVEL / PHYSICAL DEMANDS:
Travel typically less than 25%. Office environment. No special physical demands required.
The posted range for this position is $97,909-$202,806 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.
This position is eligible for a bonus not reflected in the posted range.
Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
For more information about career opportunities at Henry Schein, please visit our website at
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Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
For more information about career opportunities at Henry Schein, please visit our website at: ***************************
Fraud Alert
Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment.
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. Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal.
No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.
$97.9k-202.8k yearly Auto-Apply 25d ago
Regulatory Manager - Legal | Remote
Strada 3.2
Remote regulatory compliance manager job
Our story Strada is a technology-enabled, people powered company committed to delivering world-class payroll, human capital management, and financial management solutions to organizations globally. With a team of more than 8,000 experts and over 30 years of expertise, Strada blends leading-edge technology with human ingenuity to help businesses across the globe design and deliver at scale. Supporting over 1,400 customers in 33 countries, Strada partners with customers at every stage of their journey, to help drive their vision forward. It's why we're so driven to connect passion with purpose. Our team's experience in human insights and cloud technology gives companies and employees around the world the ability to power confident decisions, for life. With a comprehensive total rewards package, continuing education and training, and tremendous potential with a growing global organization, Strada is the perfect place to put your passion to work. To learn more about us, visit stradaglobal.com Regulatory Manager Key Responsibilities Work with legal/compliance leaders and outside consultants to establish, maintain, and evolve Strada's first standalone ESG program. In collaboration with legal/compliance leaders and business stakeholders, manage estimation and data collection of sustainability metrics. Develop technical content and best practice tools for sustainability data collection and communicate with senior leadership. Drive a strong sustainability culture by working with cross-functional teams to improve reporting, risk mitigation, and communication. Monitor and communicate evolving global sustainability regulations and their impact on operations and required corporate reporting. Lead or support sustainability initiatives and disclosures to third parties, such as EcoVadis. Support operational compliance and continuous improvement projects to reduce energy, GHG emissions, water use, and waste. Assist with gathering data for, and submission of, required reports for CSRD and other applicable global regulations. Assist sales and other business teams with responding to third-party ESG questionnaires and related requirements. Prepare and deliver data summaries and presentations on sustainability performance and compliance to stakeholders. Assist with other regulatory, compliance, and privacy projects as determined by the Global Compliance Director. About You Bachelor's degree in sustainability, environmental engineering or science, environmental studies, or equivalent technical degree. Passion for ESG and willingness to be a major contributor to the creation of a world-class ESG program. Willingness to assist with other regulatory, compliance and privacy projects relevant to Strada's business. 2-4+ years of experience leading and/or supporting corporate sustainability programs and environmental sustainability compliance. Experience compiling, reviewing, analyzing, and managing environmental sustainability data. Ability to lead and manage multiple and complex technical projects/tasks. 2-4+ years of experience in voluntary disclosures, such as EcoVadis. Experience or knowledge in operational EHS is preferred. Proficient in data management and interpreting environmental information. Strong organizational skills/attention to detail and effective communication skills, including the ability to engage in a deliberate and respectful manner with global teammates and third parties. Ability to work independently and think strategically to produce the best results for Strada. A self-motivated, driven team player capable of managing multiple tasks and working collaboratively with others to accomplish common goals in a matrixed, multinational company. Benefits We offer programs and plans for a healthy mind, body, wallet and life because it's important our benefits care for the whole person. Options include a variety of health coverage options, wellbeing and support programs, retirement, vacation and sick leave, maternity, paternity & adoption leave, continuing education and training as well as a number of voluntary benefit options. By applying for a position with Strada, you understand that, should you be made an offer, it will be contingent on your undergoing and successfully completing a background check consistent with Strada's employment policies. Background checks may include some or all the following based on the nature of the position: SSN/SIN validation, education verification, employment verification, and criminal check, search against global sanctions and government watch lists, credit check, and/or drug test. You will be notified during the hiring process which checks are required by the position. Our commitment to Diversity and Inclusion Strada is committed to diversity, equity, and inclusion. We celebrate differences and believe in fostering an environment where everyone feels valued, respected, and supported. We know that diverse teams are stronger, more innovative, and more successful. At Strada, we welcome and embrace all individuals, regardless of their background, and are dedicated to creating a culture that enables every employee to thrive. Join us in building a brighter, more inclusive future. Diversity Policy Statement Strada is an Equal Employment Opportunity employer and does not discriminate against anyone based on sex, race, color, religion, creed, national origin, ancestry, age, physical or mental disability, medical condition, pregnancy, marital or domestic partner status, citizenship, military or veteran status, sexual orientation, gender, gender identity or expression, genetic information, or any other legally protected characteristics or conduct covered by federal, state or local law. In addition, we take affirmative action to employ and advance in the employment of qualified minorities, women, disabled persons, disabled veterans and other covered veterans. Strada provides reasonable accommodations to the known limitations of otherwise qualified employees and applicants for employment with disabilities and sincerely held religious beliefs, practices and observances, unless doing so would result in undue hardship. Applicants for employment may request a reasonable accommodation/modification by contacting his/her recruiter. Authorization to work in the Employing Country Applicants for employment in the country in which they are applying (Employing Country) must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the Employing Country and with Strada. Note, this does not restrict management's right to assign or reassign duties and responsibilities of this job to other entities; including but not limited to subsidiaries, partners, or purchasers of Strada business units.
We offer you a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
Salary Pay Range
Minimum - Maximum:
$0.00 - $0.00
Pay Transparency Statement: Strada considers a variety of factors in determining whether to extend an offer of employment and in setting the appropriate compensation level, including, but not limited to, a candidate's experience, education, certification/credentials, market data, internal equity, and geography. Strada makes these decisions on an individualized, non-discriminatory basis. Bonus and/or incentive eligibility are determined by role and level.
DISCLAIMER:
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job to other entities; including but not limited to subsidiaries, partners, or purchasers of Strada business units.
Strada provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, pregnancy, childbirth or related medical condition, veteran, marital, parental, citizenship, or domestic partner status, or any other status protected by applicable national, federal, state or local law. Strada is committed to a diverse workforce and is an affirmative action employer.
$54k-89k yearly est. Auto-Apply 60d+ ago
Content Compliance Manager
The Strive Group 3.8
Remote regulatory compliance manager job
Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine.
Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference.
Our Mission
We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. ‘The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare.
Location: Remote (USA)
Position Type: Full-Time
Position Summary
The Content ComplianceManager supports Strive Pharmacy's informational content review program by ensuring all marketing, educational, and communication materials comply with applicable laws, pharmacy regulations, compounding standards, and internal policies before release. This role sits as a critical link at the intersection of Compliance, Clinical, Marketing/Communications, Brand, Sales, and Legal teams at Strive Pharmacy. The Manager will complete cross-functional reviews, set procedures, and advise on claim language and risk, ensuring alignment with federal and state requirements while enabling high-quality, on-brand communications. This role ensures that all content produced and released internally or externally by Strive Pharmacy is accurate, compliant, and aligned with FDA and FTC guidance as well as federal and state regulations. The Manager is also responsible to build the governance, workflows, and training that keep our content accurate, substantiated, and compliant across all channels (web, email, print, social, video, provider materials, patient education, packaging/labels, and point-of-care assets). The ideal candidate will combine deep regulatory expertise with a collaborative mindset, enabling Strive to maintain the highest standards of integrity while delivering engaging and compliant communications.
Key Responsibilities
Drive Compliance content review: Design, implement, and continuously improve Strive's content compliance framework (policies, SOPs, workflows, SLAs, and controls) for prescription, supplement, and OTC product lines. Train and support cross-functional teams on compliant content creation practices.
Lead cross-functional review: Prioritize and manage content review requests based on business needs, deadlines, and risk. Triage, prioritize, and approve content. Provide early-stage guidance to accelerate cycles and reduce rework. Monitor queue and enforce SLAs.
Claims & substantiation: Establish and maintain a compliant language library. Ensure appropriate qualifiers, disclaimers, and structure/function positioning for supplements. Prohibit unsubstantiated, misleading, comparative, or superiority claims. Participate in marketing/content planning meetings for upstream compliance.
Regulatory alignment: Interpret and apply USP //, FDA and FTC advertising/promotion guidance, HIPAA (marketing permissions), and relevant state board requirements to real-world assets and campaigns. Understand and advise on compliant content and communication guidelines for all Strive products and services (prescription and OTC).
Risk management: Provide timely and accurate guidance grounded in applicable laws. Stay ahead of evolving enforcement trends and emerging digital marketing risks. Monitor changes in industry or regulatory requirements impacting content.
Training & enablement: Develop compliant content playbooks, training modules, and language guides for Strive teams. Upskill teams on compliant copy, fair balance, disclosures, testimonials, endorsements, and social media practices.
Documentation & audit readiness: Build a content repository and auditable record of decisions, approvals, and rationales. Maintain documentation of all reviews and approvals for audit readiness. Prepare materials for inspections or external reviews.
Metrics & reporting: Optimize review tools/queues (e.g., Asana). Support KPIs such as review volume, cycle time, first-pass approval rate, re-work rate, escalation frequency, and SLA adherence. Standardized processes to improve efficiency and accountability. Prepare executive-level dashboards and insights to drive continuous improvement.
Collaboration with Legal/Privacy: Participate in meetings with internal and external legal counsel as needed. Partner to align on risk thresholds, required notices/permissions, patient data usage, and incident response in public channels.
Inquiry response: Take ownership over responding to compliance inquiries originating from staff throughout the organization related to content compliance questions and issues. Respond to inquiries with detail, clarity, substantiation, and recommended action/direction for the requestor.
Qualifications
PharmD (required). JD or regulatory education preferred.
3+ years in pharmacy compliance, regulatory affairs, MLR/content review, or closely related roles within healthcare, pharmacy, biotech, or digital health industries.
Direct experience in content and marketing review.
Strong knowledge of USP //, FDA/FTC marketing/advertising guidelines (including digital, social, testimonials, endorsements, and disclosures), HIPAA marketing rules, and federal and state pharmacy requirements.
Demonstrated ability to interpret complex regulations into actionable, scalable guidance and to make timely, defensible approval decisions under fast-paced deadlines.
Track record of working cross-departmentally, training non-compliance stakeholders, and influencing outcomes without formal authority.
Exceptional attention to detail and accuracy.
Excellent writing/editing skills with precision on claims, qualifiers, and consumer-friendly risk language.
Highly organized; excels at prioritization across multiple concurrent launches and deadlines.
Proactive problem-solver who offers compliant solutions and can make sound, timely decisions.
Ability to balance regulatory compliance with business objectives by guiding teams toward compliant alternatives that achieve marketing goals.
Exceptional communication skills, both written and oral.
Strong interpersonal skills with the ability to collaborate across departments and to educate and influence non-compliance stakeholders toward compliant solutions.
Exceptional skills in time management and prioritization, and the ability to manage multiple concurrent priorities and deadlines in a fast-paced environment.
Proven ability to review and approve content under tight deadlines without compromising quality or accuracy.
Commitment to ongoing professional development and staying current with regulatory changes impacting pharmacy marketing.
Experience in writing standard operating procedures (SOPs).
Proficient with Google Workspace and Microsoft Office.
Experience using Asana and Canva preferred.
Travel: Occasional (
Annual Salary$120,000-$140,000 USDBenefits/ Perks
Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members.
Culture
At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace.
EEO
Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.
Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.
$120k-140k yearly Auto-Apply 7d ago
Transportation Compliance Manager
Ecolab Inc. 4.7
Remote regulatory compliance manager job
As Transportation ComplianceManager, you drive DOT and Hazmat compliance, lead fleet safety initiatives, resolve audits, deliver regulatory training, investigate incidents, and partner with operations to ensure our private fleet's safety, performance, and continuous improvement across all compliance and reporting requirements
What You Will Do
* Lead all efforts to maintain CSA scores with FMCSA within good status for our internal private fleet.
* Lead the strategy and maintenance of our DOT employee and equipment files.
* File and renew Hazmat registrations, DOT Special Permits, and maintenance of financial and registration paperwork.
* Leading and executing issue resolution of ECAP/DOT Compliance audits for plants and terminals related to the fleet.
* Design and provide training to Fleet personnel on relevant FMSCA, PHMSA and Hazmat regulations. In addition, evaluate the existing equipment for improved ergonomic devices and accessories.
* Lead investigations into first aid, recordable injuries, violations, and vehicle accidents. Drive deep dive on root cause through 5-why analysis and RCA, identify corrective actions and follow up with resolution accountability to all parties. Review trend analysis for root causes to continue to improve program.
* Create and publish safety metrics and observation tracking with focus on re-trip inspection metrics. Partner with Fleet Operational & Maintenance Managers to drive forward improvement.
* Oversee and manage real-time DOT Compliance issues and partner with Fleet Operations Managers on pre-inspection checklists and issue resolution as needed.
Position Details
* This is a remote position. The ideal candidate will reside close to a major airport.
* Overnight Travel required - 25%
Minimum Qualifications
* Bachelor's degree in Logistics Safety or related degree
* 15+ years' experience in within the transportation, warehousing or related field
* Knowledge of DOT Hazmat and RCRA regulations
* FMSCA regulations and controlled substance programs
* Excellent problem-solving skills
* Strong verbal and written communication, leadership and training skills
* Strategic influencing ability. Able to bring together cross-functional groups to solve challenging safety solutions.
* No immigration sponsorship available
Preferred Qualifications
* Bachelor's degree in Engineering, Science, Environmental, Logistics or related discipline - significant industry experience may be used to substitute for formal education
* Previous experience in bulk liquid transportation industry
* Project management experience
Nalco Water
Our Global Water team comprises four sectors: Heavy Water, Light Water, Food & Beverage and Net Zero Solutions. We help industrial customers around the globe optimize operations and achieve business goals by providing digitally enabled, end-to-end water management and hygiene solutions. Our expertise and ongoing innovation ensure operational efficiency, safety, sustainability, and customer satisfaction.
Annual or Hourly Compensation Range
The base salary range for this position is $120,500.00 - $180,700.00. This position is eligible for annual bonus pay based on performance, per plan terms. Many factors are taken into consideration when determining compensation, such as experience, education, training, geography, etc. We comply with all minimum wage and overtime laws.
Benefits
Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits.
If you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here.
Potential Customer Requirements Notice
To meet customer requirements and comply with local or state regulations, applicants for certain customer-facing roles may need to:
* Undergo additional background screens and/or drug/alcohol testing for customer credentialing.
* Be fully vaccinated for COVID-19, including a booster if eligible, unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.
Americans with Disabilities Act (ADA)
Ecolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website.
$120.5k-180.7k yearly Auto-Apply 2d ago
Clinical Compliance Manager
Healthcare Services 4.1
Remote regulatory compliance manager job
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Clinical ComplianceManager(Solventum)
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As a Clinical ComplianceManager you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Providing leadership and oversight for the team responsible for authoring and maintaining clinical evaluation documentation, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and associated processes.
Allocating resources and monitoring timelines to ensure deliverables meet regulatory and business needs, and managing this process across the entire Dental Solutions product portfolio.
Authoring and coordinating clinical evaluations for new products and legacy devices.
Collaborating with cross-functional teams to generate a clinical evaluation that collects, analyses and assesses the clinical data pertaining to a medical device to verify the safety and performance in compliance with applicable regulations.
Owning and continuously improving the clinical evaluation process, including developing SOPs, templates, and best practices for clinical evaluation documentation.
Acting as the primary point of contact for audits and regulatory inspections related to clinical evaluation.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND seven (7) years of experience in the medical device industry
Strong knowledge of EU MDR, MEDDEV 2.7/1 and clinical evaluations, including 5 years of experience medical writing according to EU MDR or comparable experience.
2+ years of experience managing teams and complex documentation processes.
Additional qualifications that could help you succeed even further in this role include:
Dental experience in a private, public, government or military environment.
Ability to work effectively in cross-functional and cross-cultural teams.
Strong understanding of global regulatory requirements for medical devices.
Excellent organizational, leadership, and communication skills.
Proven strength in clinical and medical writing.
Ability to manage multiple complex projects simultaneously.
Strategic thinking, critical thinking, reasoning, and interpretive skills
Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
Ability to leverage AI technologies to strategically optimize team workflows, drive automation of key processes, and elevate operational efficiency across the team.
Work location: Remote - United States
Travel: May include up to 10% domestic
Relocation Assistance: Not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $160,284 - $195,903, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
terms.
$160.3k-195.9k yearly Auto-Apply 28d ago
Investment Advisory Compliance Program Office Manager
Empower Retirement 4.3
Remote regulatory compliance manager job
Our vision for the future is based on the idea that transforming financial lives starts by giving our people the freedom to transform their own. We have a flexible work environment, and fluid career paths. We not only encourage but celebrate internal mobility. We also recognize the importance of purpose, well-being, and work-life balance. Within Empower and our communities, we work hard to create a welcoming and inclusive environment, and our associates dedicate thousands of hours to volunteering for causes that matter most to them.
Chart your own path and grow your career while helping more customers achieve financial freedom. Empower Yourself.
As an Investment Advisory Compliance Program Office Manager, you will support compliance oversight for Empower Capital Management, Empower Advisory Group, and Empower Funds. You'll guide key elements of our compliance program, apply regulatory expertise, and help business partners operate with confidence. Your work strengthens our controls, supports regulatory readiness, and helps us deliver trustworthy advisory services.
What you will do:
Maintain and refresh compliance policies and procedures under the Advisers Act, Investment Company Act, and applicable FINRA/MSRB rules
Review and test controls to assess effectiveness and partner with business teams to close gaps
Prepare reports and filings for leaders, committees, and regulators
Monitor regulatory changes and summarize impacts for advisory and fund businesses
Coordinate exam and audit responses with senior compliance officers, including materials and follow-up
Support compliance training by updating content, tracking completion, and answering questions
Conduct due diligence on sub-advisers and third-party providers
Work with Compliance Operations and technology partners to enhance reporting, testing, and automation
Maintain documentation and records supporting regulatory obligations
Represent Compliance on projects and working groups to embed requirements into new initiatives
What you will bring:
Bachelor's degree or equivalent experience
5+ years in investment advisory or asset managementcompliance
Working knowledge of SEC, FINRA, and MSRB regulations
Experience supporting compliance programs in a regulated financial institution
Ability to interpret and apply complex regulations
Strong analytical, organizational, and communication skills
Comfort collaborating across teams and managing documentation
Familiarity with compliance systems, reporting tools, or data management
FINRA fingerprinting required
What will set you apart:
Advanced degree (J.D., MBA, or similar)
FINRA Series 65 (or willingness to obtain within the required timeline)
Experience with regulatory exams, audits, or control testing
Background supporting advisory or fund compliance programs
Strength in process improvement or automation tools
Proven ability to explain regulatory expectations in clear, practical terms
**Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time, including CPT/OPT.**
What we offer you
We offer an array of diverse and inclusive benefits regardless of where you are in your career. We believe that providing our employees with the means to lead healthy balanced lives results in the best possible work performance.
Medical, dental, vision and life insurance
Retirement savings - 401(k) plan with generous company matching contributions (up to 6%), financial advisory services, potential company discretionary contribution, and a broad investment lineup
Tuition reimbursement up to $5,250/year
Business-casual environment that includes the option to wear jeans
Generous paid time off upon hire - including a paid time off program plus ten paid company holidays and three floating holidays each calendar year
Paid volunteer time - 16 hours per calendar year
Leave of absence programs - including paid parental leave, paid short- and long-term disability, and Family and Medical Leave (FMLA)
Business Resource Groups (BRGs) - BRGs facilitate inclusion and collaboration across our business internally and throughout the communities where we live, work and play. BRGs are open to all.
Base Salary Range
$105,700.00 - $149,275.00
The salary range above shows the typical minimum to maximum base salary range for this position in the location listed. Non-sales positions have the opportunity to participate in a bonus program. Sales positions are eligible for sales incentives, and in some instances a bonus plan, whereby total compensation may far exceed base salary depending on individual performance. Actual compensation offered may vary from posted hiring range based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer.
Equal opportunity employer
•
Drug-free workplace
We are an equal opportunity employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to age (40 and over), race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, religion, physical or mental disability, military or veteran status, genetic information, or any other status protected by applicable state or local law.
***For remote and hybrid positions you will be required to provide reliable high-speed internet with a wired connection as well as a place in your home to work with limited disruption. You must have reliable connectivity from an internet service provider that is fiber, cable or DSL internet. Other necessary computer equipment, will be provided. You may be required to work in the office if you do not have an adequate home work environment and the required internet connection.***
Job Posting End Date at 12:01 am on:
01-17-2026
Want the latest money news and views shaping how we live, work and play? Sign up for Empower's free newsletter and check out The Currency.
$105.7k-149.3k yearly Auto-Apply 4d ago
Pharmacy Compliance Director
Knipper 4.5
Remote regulatory compliance manager job
YOUR PASSION, ACTIONS & FOCUS is our Strength.
Become one of our Contributors!
Join the KnipperHEALTH Team!
The Pharmacy Compliance Director plays a key role in maintaining the integrity, accountability, and compliance posture of the organization. This position serves as the primary lead for Accreditation, Board of Pharmacy, and client audit readiness, The Compliance Director is responsible for ensuring that all compliance issues, investigations, and corrective actions are documented, tracked, and closed effectively, and that CPS remains fully compliant with HIPAA, NABP, ACHC, DEA, and applicable state and federal pharmacy regulations.
This position reports to the the CPS Compliance Officer partners closely with Operations, Quality, and Legal teams.
Exciting remote opportunity!
Sponsorship is not being offered for this role.
Responsibilities
Compliance Program Support
Lead the execution of the Pharmacy Compliance Program, including education, monitoring, and reporting activities.
Develop and drive long-term compliance strategies aligned with organizational goals and integrate them into business planning.
Prepare and present quarterly compliance metrics, CAPA summaries, and privacy updates to the Compliance Committee. Oversee compliance risk assessments and mitigation plans.
Assist with policy development, updates, and integration into the Knipper Health corporate compliance framework.
Assist with development and execution of internal auditing procedures.
Contribute to audit readiness by maintaining organized, current evidence files for compliance and privacy controls.
Participate in internal and client audits; provide documentation and corrective follow-up.
Coordinate compliance training for employees and contractors related to HIPAA, CAPA, accreditation standards, and PBMs.
Manages and develops team members who support these processes.
Accreditation, Regulatory, Client ComplianceManagement
Serve as the Accreditation Lead for ACHC, NABP, and other certification and regulatory bodies relevant to pharmacy operations.
Maintain current knowledge of all accreditation standards and regulatory updates impacting pharmacy operations.
Lead all reaccreditation and audit readiness activities, including documentation review, evidence collection, and staff preparation.
Maintain a master library of accreditation policies, procedures, and evidence documents.
Collaborate with Quality and Operations to close accreditation-related CAPAs or deficiencies.
Ensure ongoing compliance with all accreditation standards through continuous monitoring, periodic internal audits, and staff education.
Act as the primary liaison to accrediting bodies, external auditors, and regulatory agencies.
Coordinate performance improvement and accreditation committee meetings and maintain minutes and corrective action logs.
The above duties are meant to be representative of the position and not all-inclusive.
Qualifications
MINIMUM REQUIREMENTS:
Pharm D or Bachelor of Science Degree in pharmacy
Ten (10) years of Pharmacist experience
Current unrestricted license to practice pharmacy in good standing by the required state(s) board(s) of pharmacy.
Ability to acquire other licenses as needed.
Minimum 5 years of experience in compliance, quality assurance, or regulatory affairs within a specialty or mail-order pharmacy environment.
Demonstrated experience leading accreditation/compliance programs.
Working knowledge of HIPAA Privacy & Security, NABP, ACHC, DEA, and 21 CFR Part 11.
Strong analytical and documentation skills with attention to detail and deadlines.
Proficient with compliance or QMS platforms (e.g., Track-wise, Master-Control, ZenQMS, or equivalent).
Ability to communicate effectively across clinical, operational, and executive teams.
Prior experience presenting to compliance committees or regulatory inspectors preferred.
Proficient in the area of clinical interpretation; drug-drug, drug-disease, drug-food interaction and allergies
HIPAA, Fraud Waste and Abuse and Confidentiality training
Demonstrated knowledge of regimens, products, medication, and supplies
Demonstrated experience providing exceptional customer service
PREFERRED EDUCATION AND EXPERIENCE:
Advanced degree in Pharmacy, Healthcare Administration, or related field
Previous experience in applicable pharmacy practice area
Understanding or knowledge of medication claims processing systems and/or medical information systems
Unrestricted multiple state pharmacist licenses, a plus.
KNOWLEDGE, SKILLS & ABILITIES:
Integrity & Accountability: Models ethical conduct and reinforces compliance culture.
Critical Thinking: Skilled in analyzing root causes, patterns, and systemic risks.
Leadership & Collaboration: Partners cross-functionally to drive sustainable improvements.
Technical Proficiency: Demonstrated understanding of pharmacy operations, data protection, and regulatory standards.
Communication: Clear, concise, and confident in reporting findings and recommendations.
Excellent written and verbal communication skills
Excellent analytical, problem solving and decision-making skills
Computer skills including Microsoft Office products
Ability to accept changing work-flows and unexpected demands
Ability to work under pressure and appropriately prioritize responsibilities
Ability to work independently with minimal supervision
Ability to work in a team-oriented environment and develop collaborative working relationships
Ability to enter data and retrieve patient information
Ability to present information clearly and professionally to varying levels of individuals throughout the patient care process
PHYSICAL DEMANDS:
Location of job activities 100% inside
Noise and/or vibrations exposure
Reaching (overhead), handling, and feeling
Stand and sit for prolonged periods of time
Extensive manual dexterity (keyboarding, mouse, phone)
Use of phone for communication
Ability to travel out of state 25%
Lift, carry, and move up to 20 pounds
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Knipper Health is an equal opportunity employer
$81k-125k yearly est. Auto-Apply 4d ago
Compliance Lead, Regulatory Compliance
EQT 4.6
Remote regulatory compliance manager job
EQT is one of the United States' leading producers of natural gas and the first traditional energy company of scale in the world to achieve Net Zero on a Scope 1 and Scope 2 basis.
From the office to the field, the #EQTeam is fueling the future. Power your potential with us.
At EQT, we are making strides toward becoming the best producer by creating long-term value for all stakeholders, including employees, landowners, communities, industry partners and investors. Our vision is to evolve EQT into a modern, connected, digitally enabled organization.
With an incredibly collaborative culture and a determined, progressive workplace, EQT was both named a National Top Workplace, as well as one of Pittsburgh's Best Places to Work!
Join our Qrew!
The Compliance Lead, Regulatory Compliance supports EQT's enterprise compliance framework by leading execution of key regulatory compliance activities throughout the organization. This role coordinates regulatory tracking, impact assessment, and change management efforts, ensuring that new or evolving requirements are efficiently assessed, communicated, and integrated into business operations.
Working cross-functionally with Legal, Operations, Upstream, Midstream, Environmental, and Safety teams, this position helps drive consistency, strengthen controls, and reinforce a culture of proactive compliance across the organization.
The Compliance Lead, Regulatory Compliance responsibilities include but are not limited to:
Maintain EQT's regulatory repository and compliance control documentation to ensure requirements remain current, traceable, and actionable.
Track and assess regulatory developments affecting upstream and midstream operations, as well as the domestic and international supply of natural gas to customers.
Lead the regulatory impact assessment process, coordinating input from business stakeholders to evaluate applicability and operational impact.
Partner with compliance champions and process owners to embed regulatory obligations into procedures, training, and monitoring activities.
Support the development and execution of remediation and control improvement plans for identified compliance risks or findings.
Analyze preventable notices of violation (NOVs) and similar enforcement actions to identify root causes and drive sustainable corrective actions.
Coordinate compliance change management activities, ensuring updates to requirements are communicated, documented, and operationalized.
Provide data-driven insights to inform compliance reporting, audits, and management reviews.
Contribute to continuous improvement initiatives by identifying efficiency opportunities in compliance monitoring, documentation, and reporting.
Required Experience and Skills:
Bachelor's degree in law, engineering, environmental science, business, or a related discipline.
7-10 years of progressive regulatory compliance experience in the natural gas, midstream, or broader energy sector.
Proven ability to interpret, implement, and operationalize requirements from agencies such as FERC, PHMSA, EPA, OSHA, and state-level regulators.
Experience maintaining compliance repositories, impact assessments, or control frameworks.
Strong analytical and problem-solving skills, with the ability to assess regulatory risk and drive remediation activities.
Excellent communication and collaboration skills; able to influence and coordinate across diverse teams and functional areas.
Demonstrated integrity, judgment, and discretion when managing sensitive or confidential information.
Skilled in managing multiple priorities and adapting to a dynamic regulatory environment.
Proficiency with GRC platforms, data analytics, or regulatory tracking systems preferred.
Preferred Experience and Skills:
Advanced degree (JD, MBA, or master's) or professional certification (CCEP, CRCM, CPCU, CAMS).
Experience supporting or enhancing compliancemanagement systems and regulatory reporting tools.
Strong understanding of regulatory frameworks and enforcement practices relevant to the natural gas industry.
Prior experience coordinating compliance change management or regulatory implementation projects.
Effective at developing presentations and reports for business and regulatory audiences.
Ability to mentor junior compliance staff or serve as a subject matter resource within the compliance program.
Remote work is being considered for this role excluding the following states: California, Connecticut, Delaware, Illinois, Indiana, Louisiana, Massachusetts, Michigan, New Jersey, New York, and Tennessee unless willing to relocate.
Selected incumbent will be placed into the position that best suits their abilities and experience level.
EQT Corporation and its subsidiaries is an Equal Opportunity Employer -- Disabilities/Veterans.
$89k-123k yearly est. Auto-Apply 49d ago
Regulatory Affairs Lead, Oncology (Sr. Manager)
Astellas Pharma, Inc. 4.9
Remote regulatory compliance manager job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
* Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with considerable technical complexity and diversity requiring impact on internal decision making. The assigned area responsibility may be focused on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a within a region.
* Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted problem solving and internal decision making.
* Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products.
* Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies.
* Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects/products reflect up-to-date regulatory strategies.
* May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues.
* Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products.
Responsibilities and Accountabilities:
Regulatory Excellence
* Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or commercial products and is accountable for the expert review of major deliverables from a regulatory perspective.
* Leads regulatory development in GRL or regional regulatory lead roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs with considerable complexity requiring impact on internal and external decision making.
* Applies understanding of regulatory requirements and trends into the development of aligned regulatory strategies.
* Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals.
* Accountable for the preparation and submission of technical documents to regulatory authorities for assigned projects/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, quality, interpretation and regulatory/scientific rigor to drive success with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory strategy into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications.
* Collaborates with GRA management to provide oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies.
* Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks.
* Provides regulatory expertise for planning, approving regulatory content.
* Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and contributes to the preparation of recommendations and robust opinions for management in a timely manner.
* Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues.
* May provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA.
* Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products. Builds and maintains good relationships with Regulatory Authorities.
Organization & People Management
* Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc).
* Represents GRA within project/product teams and collaborates with global Astellas stakeholders to affect global strategies and consistency in regulatory messaging.
$88k-125k yearly est. 60d+ ago
Director, Cold Chain Management & GDP Compliance
Biomarin Pharmaceutical Inc. 4.6
Remote regulatory compliance manager job
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Director Cold Chain Management & GDP Compliance
Fully remote role, US Candidates
SUMMARY DESCRIPTION
The Director, Cold Chain Management & Supply Chain GDP is a key role as part of the Global Distribution organization. This role is critical to ensuring the integrity of temperature-sensitive pharmaceutical products throughout the supply chain, while maintaining full compliance with Good Distribution Practice (GDP) regulations and internal quality standards.
The incumbent will lead the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of all clinical and commercial materials in BioMarin.
RESPONSIBILITIES
Cold Chain Engineering
* Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products.
* Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities.
* Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets.
* Drive innovation in cold chain technologies and the streamlined management and quality of associated data.
Supply Chain Compliance & GDP
* Ensure global compliance with GDP regulations and internal quality standards across all distribution channels.
* Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity.
* Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations.
* Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps.
Leadership & Strategy
* Direct management of a team of individual contributors across global regions
* Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities.
* Advise senior leadership on investment decisions and emerging trends, providing timely risk insights and strategic recommendations that support informed decision-making.
SCOPE
This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner.
The candidate should demonstrate the following attributes:
* A firm commitment to BioMarin's cultural beliefs and values
* Consistent track record of exceeding objectives within area of influence
* Ability to achieve results through others without direct reporting lines
* Strong problem-solving skills with a global focus both internally and externally
* Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry
* Flexibility and ability to deal with changing priorities without losing sight of the overall business
* Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change
* Proactive and energetic outlook with an unwillingness to accept the status quo
* Interaction and collaboration with team members, peers and senior management
* Ability to work independently with strong time management skills
EDUCATION
* Bachelor's or Master's degree in Engineering, Supply Chain, Life Sciences, or related field.
* 10+ years of experience in pharmaceutical supply chain, with significant expertise in cold chain and GDP compliance.
* Proven leadership experience in a global, matrixed organization.
* Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.).
* Excellent communication, stakeholder management, and problem-solving skills.
Preferred Qualifications:
* Experience with biologics, vaccines, or advanced therapies.
* Familiarity with digital monitoring systems and data analytics in cold chain.
* Lean Six Sigma or similar process improvement certification.
EXPERIENCE
* Bachelor's degree in related curriculum with a minimum of 10-12 years of experience in global trade compliance
* Previous experience leading a global team
* Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes).
* Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions to make the company's Trade Compliance stronger and more efficient.
* Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk
* Ability to effectively work autonomously and independently
Circa 15% travel
CONTACTS
Commercial, Site Operations, Clinical Supply Chain Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance
External partners including 3PL providers, transport carriers.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The salary range for this position is: $169,300 to $253,900. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
$169.3k-253.9k yearly 48d ago
Temp to Perm - Remote Opportunity - Regulatory Affairs Manager
Collabera 4.5
Remote regulatory compliance manager job
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
Job Description
Required: (Remote Opportunity - Temp to Perm)
• The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
• In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
• The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
• Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
• Lead Regulatory Associates or Specialists in addition to work as an individual contributor
• Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
• Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
• Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
• Monitor and provide management with impact of changes in the Regulatory environment.
• Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
• Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
• Support Design Control process.
• Prepare Rational to file documentation for modifications to devices when appropriate.
• Participate in FDA & other notified body Inspections.
• Author and/or review regulatory procedures and update as necessary.
• Review change control documents and ascertain Regulatory impact for external and internal documents.
• Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
• Review promotional material and labeling for regulatory compliance.
Qualifications
Required qualifications:(Remote Opportunity)
• Bachelor's degree required. Scientific or engineering field preferred.
• 5+ years of medical device regulatory affairs experience.
• Must have authored 510(k) submissions
• Must have knowledge of U.S. FDA regulations and standards
• 3+ years of experience interacting with FDA and/or other regulatory agencies
• Experience with devices containing software is strongly preferred.
• Must work well in team environments
• Must demonstrate leadership skills in team setting.
• Proven analytical abilities
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
Additional Information
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
************
ujjwal.mane[@]collabera.com
$111k-151k yearly est. 60d+ ago
Foreign Trade Zone Compliance Manager
Express, Inc. 4.2
Regulatory compliance manager job in Columbus, OH
About PHOENIX PHOENIX Retail, LLC is a retail platform operating the Express and Bonobos brands worldwide. Express is a multichannel apparel brand dedicated to a design philosophy rooted in modern, confident and effortless style whether dressing for work, everyday or special occasions. Bonobos is a menswear brand known for being pioneers of exceptional fit and a personalized, innovative retail model. Customers can experience our brands in over 400 Express retail and Express Factory Outlet stores, 50 Bonobos Guideshops, and online at *************** and ****************
About Express
Express is a multichannel apparel brand dedicated to creating confidence and inspiring self-expression. Since its launch in 1980, the brand has embraced a design philosophy rooted in modern, confident and effortless style. Whether dressing for work, everyday or special occasions, Express ensures you look and feel your best, wherever life takes you.
The Company operates over 400 retail and outlet stores in the United States and Puerto Rico, the express.com online store and the Express mobile app.
Responsibilities
The Foreign Trade Zone (FTZ) ComplianceManager is the subject matter expert responsible for all aspects of operating a zone and initiatives to streamline the import process to maintain compliance with import regulations within the ICRS system. This role will be responsible for establishing control-related standards, strict adherence to CBP's ICRS requirements, and CTPAT Security requirements, including maintaining accurate physical/digital inventory records, and managing the flow of merchandise into and out of the zone to optimize duty deferral and operational efficiency. In addition, the manager will also be responsible for the FTZ systems (ICRS), including maintenance, troubleshooting, and enhancements. The FTZ ComplianceManager will need to have deep institutional knowledge and understanding of the Foreign-Trade Zones Board regulations, and the Customs regulations, and how these apply to and impact the FTZ operations.
KEY RESPONSIBILITIES
FTZ Operational
* End-to-end management of zone processes, including zone transfers.
* Responsible for updating and maintaining FTZ Procedures Manual, Process Flows, and SOPs.
* Manage the execution and filing of all required CBP forms for merchandise admissions (CBPF 214) and removals for consumption (CBPF 3461/7501).
* Maintain FTZ files and retain FTZ records as required by law and regulations.
* Responsible for monitoring the savings associated with the FTZ operations.
* Create periodic FTZ reports (Quarterly HMF, Yearly Blanket CBP form 216, Annual Reconciliation, Certification Letter, FTZ Board Report, etc.).
* Coordinate with Finance regarding payment of quarterly HMF payments, and FTZ Operator bond premium.
FTZ Data Analytics & Reconciliation
* Oversee real-time inventory tracking within the WMS/ICRS and conduct regular, documented cycle counts and physical inventory reconciliations.
* Implement daily automated inventory reconciliation processes.
* Investigate and resolve inventory imbalances.
* Perform root cause analysis on systemic issues.
* Analyze data to create FTZ metrics and KPIs to identify areas of risk and opportunities.
Compliance & Regulatory Oversight
* Oversee admission and entry documentation accuracy.
* Process reconciliation, and post admission corrections within the defined time limits.
* Support CBP audits and examinations.
* Maintain FTZ recordkeeping requirements.
* Support the international trade team with adherence to compliance policies and procedures, in achieving operational objectives, and in fostering a culture of compliance.
* Ensure the FTZ facility adheres to all CTPAT physical security standards and manage security incident response planning.
* Monitor Customs/Regulatory environment changes and adjusting procedures as required.
Vendor & Stakeholder Management
* Oversee outsourced FTZ operational partners.
* Monitor vendor performance and SLA compliance.
* Interface with warehouse operations teams.
* Manage escalations and issue resolution.
* Partner with internal stakeholders to identify process improvements and implement solutions.
* Maintain relationship with FTZ Board, and Grantee.
* Maintain a positive working relation with US Customs and Border Protection.
* Serve as liaison with other functional areas within the organization and external partners to ensure the information systems are maintained, updated and accurate for FTZ reporting and compliance purposes.
* Work with cross functional teams on strategic initiatives to reduce spend and optimize FTZ capabilities.
* Assist in internal and external training.
Process Improvement & Risk Management
* Lead internal FTZ audit activities to identify and correct compliance issues and minimize risk.
* Leverage technology and data to streamline processes and improve efficiency.
* Identify process gaps causing inventory imbalances.
* Create risk mitigation strategies.
* Implement best practices for FTZ operations.
* Support continuous improvement initiatives.
REQUIRED EXPERIENCE & QUALIFICATIONS
Education:
* Bachelor's degree in international trade, supply chain, or the equivalent combination of education plus experience.
Experience:
* 5+ years of experience in Foreign Trade Zone operations and trade compliance, experience with FTZ warehouse transitions beneficial. 3+ years in data analytics or inventory management.
* Experience with ERP systems like SAP or Oracle to manage inventory movement.
* Experience using Inventory Control and Recordkeeping Systems (ICRS).
* Background in vendor management preferred
Knowledge:
* Strong understanding of FTZ regulations (19 CFR 146).
* Knowledge of import entry process with CBP and other government agencies.
* Knowledge of apparel importing preferred.
* Proficiency in data analytics is preferred.
* Certified Customs Specialist and/or a Customs Broker's License is beneficial.
CRITICAL SKILLS & ATTRIBUTES
Technical:
* Inventory Control Expertise
* Advanced problem-solving and root cause analysis
* Data analysis and reporting skills
* Variance detection and reconciliation
* Process mapping and optimization
Leadership Abilities:
* Ability to work independently and build from ground up
* Change management capabilities
* Vendor oversight and negotiation skills
* Cross-functional influence without direct authority
* Strategic thinking with tactical execution
Communication:
* Ability to translate data into actionable insights
* Clear and concise documentation and reporting
* Vendor relationship management
Personal Attributes:
* Meticulous and Detail-Oriented
* Self-directed and proactive
* Adaptable and effective in a transitional environment
* Collaborative approach
* Strong organizational skills
* Continuous improvement mindset
Closing
If you would like to know more about the California Consumer Privacy Act click here.
An equal opportunity employer, PHOENIX does not discriminate in recruiting, hiring or any other terms and conditions of employment hiring on the basis of any federal, state, or locally protected characteristic. PHOENIX only hires individuals authorized for employment in the United States. PHOENIX is committed to providing reasonable accommodation to individuals with disabilities. If you need an accommodation to search and apply for a job position due to a disability, please call ************** and say 'Associate Relations' or send an e-mail to ****************************** and let us know the nature of your request and your contact information.
Notification to Agencies: Please note that PHOENIX does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, PHOENIX will not consider or approve payment to any third-parties for hires made.
$76k-112k yearly est. Auto-Apply 6d ago
Director, Fintech Compliance
Toast 4.6
Remote regulatory compliance manager job
Toast is driven by building the all-in-one restaurant platform that helps restaurants operate their business, increase sales, engage guests, and keep employees happy. The Toast Fintech Compliance Program provides a compliance by design embedded approach to compliance program management , with an emphasis on product lifecycle management, while enabling the business to innovate and deliver quality products and solutions to serve our customers. Toast, Inc. seeks a strategic, commercially oriented, forward thinking Director to lead the Compliance organization supporting the Fintech business.
Reporting to the Chief Compliance Officer, the Director is responsible and accountable for establishing, managing, and maintaining quality compliance programs for Fintech products and directing the Fintech compliance team in the ongoing management of the product specific compliancemanagement systems. Products in scope include: commercial lending program, leases, commercial deposit account, payment facilitation, debit cards, prepaid payroll cards, earned wage access, billpay and stored value cards. This role is also responsible for the maintenance of state money transmitter licenses and compliance with associated requirements.
About this
roll
* (Responsibilities):
Compliance leader managingcompliance team supporting Fintech products.
Oversee the development and maintenance of product-specific compliancemanagement programs within Toast's Fintech Line of Business. Direct the Fintech Compliance team on establishing best-in-class compliancemanagement systems, mitigation of key compliance risks related to in-scope products, and the remediation of process and control gaps. Products in scope include: commercial lending program, leases, commercial deposit account, payment facilitation, debit cards, prepaid payroll cards, earned wage access, billpay and stored value cards.
Serve as a compliance thought partner to Fintech business stakeholders in the design and implementation of products/product enhancements. Guide Fintech Compliance team in product reviews to ensure regulatory compliance requirements are met.
Serve as compliance sponsor on compliance committees. Escalate key compliance risks and issues to Chief Compliance Officer and governing bodies, such as the Enterprise Risk and Compliance Committee.
Review results from compliance testing programs to identify themes or trends in findings and gaps. Mature and enhance Fintech compliance program and/or framework to address.
Ensure product specific regulatory changes are monitored and assessed, and communicated to business partners in a timely manner.
Oversee partner relationships and ensure obligations are met, including, but not limited to timely and accurate reporting and successful completion of partner reviews and required testing. Serve as an escalation point for concerns and issues raised by key partner contacts.
Maintain state money transmitter licenses and compliance with associated requirements.
Do you have the right
ingredients*
? (Requirements):
Bachelor's Degree required and CRCM preferred.
Strong knowledge of financial laws and regulations, including: CFPB regulations (most specifically Reg B, Reg E, Reg P, and Reg Z); federal and state consumer protection laws (most specifically UDA(A) P, CAN SPAM, and TCPA); other laws and industry best practices related to commercial and consumer credit, prepaid debit cards, and electronic funds transactions; money transmitter laws, and card association and payment network rules.
Direct experience leading compliance programs for financial products and services, specifically payment processing, money transmission, and banking products which may include: commercial and consumer credit, purchase financing, deposit accounts, debit, credit, and stored-value cards, bill pay services, and earned wage access.
Typically requires 15+ years of related experience with a Bachelor's degree; or 12+ years and a related Master's degree.
10+ years of experience in a compliance, risk, or audit role at a financial institution providing commercial and/or consumer non-investment banking products (Fintech or payments industry preferred).
Experience maintaining fintech-oriented frameworks, bank partnerships and third party vendors programs.
Familiarity with operational processes and regulations related to banking products. Ability to work well with ambiguity and synthesize large amounts of complex information.
Strong communication skills (both written and verbal).
Special Sauce (Nice-to-Have Skills):
CAMS
AI at Toast
At Toast we're Hungry to Build and Learn. We believe learning new AI tools empowers us to build for our customers faster, more independently, and with higher quality. We provide these tools across all disciplines, from Engineering and Product to Sales and Support, and are inspired by how our Toasters are already driving real value with them. The people who thrive here are those who embrace changes that let us build more for our customers; it's a core part of our culture.
Our Spread* of Total Rewards
We strive to provide competitive compensation and benefits programs that help to attract, retain, and motivate the best and brightest people in our industry. Our total rewards package goes beyond great earnings potential and provides the means to a healthy lifestyle with the flexibility to meet Toasters' changing needs. Learn more about our benefits at ********************************************
#LI-REMOTE
The base salary range for this role is listed below. The starting salary will be determined based on skills and experience. In addition to base salary, our total rewards components include cash compensation (overtime, bonus/commissions, if eligible), benefits, and equity (if eligible).
Pay Range$171,000-$274,000 USD
Diversity, Equity, and Inclusion is Baked into our Recipe for Success
At Toast, our employees are our secret ingredient-when they thrive, we thrive. The restaurant industry is one of the most diverse, and we embrace that diversity with authenticity, inclusivity, respect, and humility. By embedding these principles into our culture and design, we create equitable opportunities for all and raise the bar in delivering exceptional experiences.
We Thrive Together
We embrace a hybrid work model that fosters in-person collaboration while valuing individual needs. Our goal is to build a strong culture of connection as we work together to empower the restaurant community. To learn more about how we work globally and regionally, check out: *********************************************
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Toast is committed to creating an accessible and inclusive hiring process. As part of this commitment, we strive to provide reasonable accommodations for persons with disabilities to enable them to access the hiring process. If you need an accommodation to access the job application or interview process, please contact candidateaccommodations@toasttab.com.
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For roles in the United States, It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$171k-274k yearly Auto-Apply 31d ago
Learn more about regulatory compliance manager jobs