Regulatory Compliance Director remote jobs - 240 jobs
Regulatory & Government Affairs Counsel - Remote
Point 4.2
Remote job
A financial services company based in Palo Alto is looking for an experienced Associate General Counsel to support regulatory compliance and government relations. The successful candidate will have a J.D., be eligible for in-house practice, and possess 4-7 years of relevant experience. Responsibilities include managing regulatory frameworks, collaborating with legislative representatives, and advocating for consumer finance standards. This role is remote-first, allowing flexibility while contributing to a mission-driven culture.
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$98k-145k yearly est. 5d ago
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Payroll Director - Hybrid, Compliance & Operations
Aspiranet 4.0
Remote job
A leading nonprofit organization in California is seeking a Payroll Director to manage payroll operations for 1,000 employees, ensuring compliance with regulations and leading audits. The ideal candidate will have significant experience in a high-volume payroll environment, and knowledge of California payroll regulations. This role offers a competitive salary and a flexible hybrid working schedule.
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$74k-109k yearly est. 6d ago
Remote Market VP Pharmacy Compliance & Practice
Humana Inc. 4.8
Remote job
A leading healthcare organization is seeking a Market Vice President of Pharmacy Professional Practice to oversee pharmacy compliance across various settings. This role requires a Bachelor's degree in Pharmacy and at least 5 years of relevant experience. The candidate will ensure regulatory compliance and lead a high-performing team. Candidates should possess extensive pharmacy knowledge and significant management experience. This position offers competitive compensation and requires occasional travel for meetings and training.
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$96k-120k yearly est. 2d ago
Global Trade Compliance Manager
The Clorox Company 4.6
Remote job
Clorox is the place that's committed to growth - for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #CloroxIsThePlace (**************************************************************************** UpdateUrns=urn%3Ali%3Aactivity%3A**********048001024)
**Your role at Clorox:**
As part of the Global Stewardship team, this individual will be the Global Trade Compliance (GTC) Regional Lead for US and Canada. The role will have responsibility for import/export GTC matters in the region and ownership of various global GTC programs. As the GTC SME for the region, the role will proactively and strategically partner with the business, and cross-functionally, to advise and problem solve.
This position will either be a hybrid role, working 2 days a week in the Pleasanton, CA office, or it will be a fully remote position based in the United States.
**In this role, you will:**
+ Develop, improve, and maintain all aspects of Clorox's GTC programs pertaining to imports/exports in the US and Canada.
+ Manage regional import/export related activities, including, but not limited to, determine HS classifications, monitor tariffs, oversee country of origin and free trade agreement qualifications, optimize customs valuation practices and manage U.S. Reconciliation filings, ensure accuracy of customs declarations, support export controls, sanctions, anti-boycott, and CTPAT matters.
+ Work collaboratively with the:
+ Import/Export Operations team to ensure implementation of GTC policies and procedures, supportday to day decision-making and facilitate resolution on key customs matters.
+ Regulatory Team to identify and manage non-tariff barriers such as EPA and FDA requirements for imports/exports.
+ Other GTC Regional Leaders for cross-border trade matters.
+ Partner functions including Legal, Strategic Sourcing, Supply Chain, Sales, R&D, and Manufacturing.
+ Manage internal/external audits and communications with government officials, including advocating positions.
+ Monitor technical developments for their region and timely communicate to cross-functional partners and stakeholders.
+ Collaborate with third parties engaged to ensure compliance with trade laws and regulations and monitor performance.
+ Represent GTC in cross-functional, strategic projects and initiatives. This includes:
+ Advise on strategy, design project plans, and manage execution to ensure compliance, customs duties optimization, and operational efficiency.
+ Identify alternative options/solutions and effectively communicate pros and cons to stakeholders to ensure sound decision-making.
+ Detect issues and proactively take the initiative to effect positive change, enhance compliance and increase efficiency.
+ Work collaboratively with other Regional GTC Leaders to share initiatives and develop and executive global strategies.
+ Understand industry best practices and constantly evaluate Clorox's practices to identify automation and improvement opportunities
+ Take ownership of global GTC programs affecting all the regions (including classification, country of origin, free trade agreements, customs valuation, sanctions, restricted party screening, internal audits, GTC input to IT implementations):
+ Ensure constant improvement and optimization/efficiency of the global GTC program.
+ Own all aspects of strategy & execution of global GTC program.
+ Develop and improve processes, including for cross functional partners' support, and monitor adherence to process.
**What we look for:**
+ Bachelors Degree or equivalent number of years of industry experience
+ 8+ years experience with import/export global trade compliance matters
+ Active US Customs License
+ US Reconciliation filling
+ Consulting &/or relevant in-house experience
+ Deep understanding of and practical experience in:
+ WTO, WCO, US, and Canada legal framework for the determination of HS classifications, country of origin, and customs valuation
+ Determining FTA eligibility for US and Canada FTAs and performing adequate levels of due diligence to substantiate FTA claims
+ Setting up global trade compliance policies and procedures
+ Setting up new supply chains, including: 1) identifying all GTC related issues; 2) making decisions about correct customs data ( _e.g._ , HS classification, FTAs, customs valuation); 3) advising and influencing others to appreciate the GTC perspective; and 4) devising and executing implementation plans
+ Good understanding and practical experience in the following areas: Law and regulations as they relate to Denied & Restricted Party Screening, Export Controls and Sanctions management, & Anti-boycott; Identifying and managing non-tariff barriers ( _e.g.,_ EPA, FDA import/export regulatory matters); Import/export laws and regulations in countries outside the US and Canada, particularly in Asia Pacific (Desirable)
+ Strong analytical and problem solving skills
+ Proactive, solutions orientated, and able to move easily between strategic thinking and being detail orientated
+ Strong all-round stakeholder management and interpersonal skills with an ability to influence to achieve the right and best outcomes
+ Can create and maintain strong working relationships internally and externally, with the ability to collaborate and understand the perspectives of others and find common ground for the development of holistic solutions
+ Proven ability to manage external customs and other government agency audits and to generally advocate a position to government officials effectively
+ Clear and concise written and oral communication skills
+ Able to explain complex concepts in clear and simple ways to stakeholders and non-experts
+ Self-motivated, able to work independently as well as part of a team, including global teams
+ Flexible, adaptable and open-minded, with a continuous improvement mentality
+ Business and commercial acumen - strong ability to appreciate and consider business perspectives, including the ability to appropriately prioritize, judge and communicate materiality
+ Must have high integrity and perform job in an ethical manner
+ Good understanding and practical experience with import/export
+ laws and regulations in countries outside the US and Canada,
\#LI-Remote
**Workplace type:**
This position will either be a hybrid role, working 2 days a week in the Pleasanton, CA office, or it will be a fully remote position based in the United States.
**Our values-based culture connects to our purpose and empowers people to be their best, professionally and personally. We serve a diverse consumer base which is why we believe teams that reflect our consumers bring fresh perspectives, drive innovation, and help us stay attuned to the world around us. That's why we foster an inclusive culture where every person can feel respected, valued, and fully able to participate, and ultimately able to thrive.** Learn more (********************************************************************************************************* **.**
**[U.S.]Additional Information:**
At Clorox, we champion people to be well and thrive, starting with our own people. To help make this possible, we offer comprehensive, competitive benefits that prioritize all aspects of wellbeing and provide flexibility for our teammates' unique needs. This includes robust health plans, a market-leading 401(k) program with a company match, flexible time off benefits (including half-day summer Fridays depending on location), inclusive fertility/adoption benefits, and more.
We are committed to fair and equitable pay and are transparent with current and future teammates about our full salary ranges. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation based on performance. Based on the breadth of our ranges, most new hires will start at Clorox in the first half of the applicable range. Your starting pay will depend on job-related factors, including relevant skills, knowledge, experience and location. The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area.
-Zone A: $106,700 - $204,900
-Zone B: $97,800 - $187,900
-Zone C: $88,900 - $170,800
All ranges are subject to change in the future. Your recruiter can share more about the specific salary range for your location during the hiring process.
This job is also eligible for participation in Clorox's incentive plans, subject to the terms of the applicable plan documents and policies.
Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times.
To all recruitment agencies: Clorox (and its brand families) does not accept agency resumes. Please do not forward resumes to Clorox employees, including any members of our leadership team. Clorox is not responsible for any fees related to unsolicited resumes.
**Who we are.**
We champion people to be well and thrive every single day. We're proud to be in every corner of homes, schools, and offices-making daily life simpler and easier through our beloved brands. Working with us, you'll join a team of passionate problem solvers and relentless innovators fueled by curiosity, growth, and progress. We relish taking on new, interesting challenges that allow our people to collaborate and thrive at work. And most importantly, we care about each other as multifaceted, whole humans. Join us as we reimagine what's possible and work with purpose to make a difference in the world.
**This is the place where doing the right thing matters.**
Doing the right thing is the compass that guides every decision we make-and we're proud to be globally recognized and awarded for our continuous corporate responsibility efforts. Clorox is a signatory of the United Nations Global Compact and the Ellen MacArthur Foundation's New Plastics Economy Global Commitment. The Clorox Company and its Foundation prioritize giving back to the communities we call home and contribute millions annually in combined cash grants, product donations, and cause-marketing. For more information, visit TheCloroxCompany.com and follow us on social media at @CloroxCo.
**Our commitment to diversity, inclusion, and equal employment opportunity.**
We seek out and celebrate diverse backgrounds and experiences. We're always looking for fresh perspectives, a desire to bring your best, and a nonstop drive to keep growing and learning. Learn more about our Inclusion, Diversity, Equity, and Allyship (IDEA) journey here (*********************************************** .
The Clorox Company and its subsidiaries are an EEO/AA/Minorities/Women/LGBT/Protected Veteran/Disabled employer. Learn more to Know Your Rights (*********************************************************************************************** .
Clorox is committed to providing reasonable accommodations for qualified applicants with disabilities and disabled veterans during the hiring and interview process. If you need assistance or accommodations due to a disability, please contact us at ***************** . Please note: this inbox is reserved for individuals with disabilities in need of assistance and is not a means of inquiry about positions/application statuses.
The Clorox Company and its subsidiaries are an EEO/AA/ Minorities/Women/LGBT/Protected Veteran/Disabled employer.
$106.7k-204.9k yearly 30d ago
Global Head, Regulatory Affairs - Labeling (PDx)
Gehc
Remote job
SummaryThe Global Head, Regulatory Affairs - Labeling sets the enterprise labeling vision and delivers the strategic labeling agenda across PDx: from target product profile (TPP) and target product labeling (TPL) through Company Core Data Sheet (CCDS) stewardship and global implementation. This leader ensures that labeling is a core lever for product positioning and market access, translating clinical and CMC evidence into precise, defensible labeling language that differentiates our portfolio and enables compliant promotion and reimbursement. The role owns the end to end global labeling framework, governance, metrics, and systems, and leads high stakes agency negotiations to defend labeling and secure optimal indications and claims.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description
Key Responsibilities:
Strategic Labeling & Product Positioning
Lead the global labeling strategy for all PDx products (development and marketed), aligning with TPP/TPL and commercial strategies to enable optimal indications, claims, and competitive positioning.
Provide early, proactive feedback on clinical and CMC plans (Phase I-III and LCM) to shape endpoints, analyses, and evidence packages that unlock the best label and access outcomes.
Chair the Global Labeling Committee and Labeling Working Groups, driving crisp decisions, risk/benefit trade‑offs, and cross‑functional alignment.
CCDS Ownership & Global Implementation
Own CCDS creation, maintenance, and change control; ensure timely, consistent roll‑out into US, EU, China, Japan and other markets, with documented exceptions and transparent rationale.
Establish and track labeling KPIs (e.g., cycle times, first‑pass acceptance, variation close‑out, deviation rate) and drive continuous improvement across processes, templates, and training.
Agency Engagement & Negotiation
Serve as the principal labeling negotiator with FDA, EMA/NCAs, NMPA (China), PMDA (Japan) and other authorities; lead labeling‑focused meetings and written interactions to defend indication, population, claims, dosing, warnings, and promo‑relevant language.
Anticipate and mitigate labeling risks that lead to CRLs, REMS/PMR/PMC obligations, or restrictive language; escalate and resolve issues decisively.
Cross‑Functional Influence & Commercial Enablement
Partner with Market Access, Commercial, Medical, and Legal/Promo Review to ensure label‑to‑launch readiness and compliant promotional scope aligned to positioning and payer needs.
Translate complex regulatory concepts into clear executive narratives; influence senior stakeholders on evidence/label trade‑offs and go‑to‑market implications.
Operating Model, Systems & Compliance
Build and evolve the Global Labeling Center of Excellence, including governance, end‑to‑end processes, metrics, inspection readiness, and systems (e.g., Veeva RIM, ePI).
Ensure audit/inspection readiness and robust documentation across labeling decisions, deviations, and exceptions.
Ad Promo Oversight
Work with the Global Head RA, Ad Promo to provide the overarching leadership, alignment, and governance needed to ensure consistency between labeling, promotional claims, product positioning, market access needs, and global regulatory expectations.
Qualifications:
Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical companies, with a record of successful label negotiations and defense at FDA/EMA/NMPA/PMDA.
Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial to shape development and lifecycle plans toward best‑possible labeling and access.
Deep expertise in CCDS, core/product information, and global/local labeling execution (US/EU at minimum).
Exceptional negotiation and stakeholder management skills, internally and externally; proven ability to craft precise, defensible labeling language from clinical data.
Strong people leadership: building high‑performing teams, setting standards, and coaching labeling professionals and cross‑functional contributors.
Desired Characteristics:
Hands‑on experience with Veeva RIM and labeling systems; understanding of ePI evolution.
Prior stewardship of a Global Labeling Committee/Working Group with measurable KPI improvement.
Advanced degree in life sciences or pharmacy; Market Access literacy to connect label language to reimbursement and promo scope.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $172,800.00-$259,200.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: February 16, 2026
$172.8k-259.2k yearly Auto-Apply 5d ago
Director, CMC and Device Regulatory Affairs
Apogee Therapeutics
Remote job
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary
The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives.
Key Responsibilities
Develop and implement global CMC and device regulatory strategies for assigned program(s)
Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
Identify regulatory risks associated with product development and propose mitigation strategies
Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
Archive and maintain regulatory submissions and correspondences in Apogee's regulatory information management system
Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth
Ideal Candidate
Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
Proven track record of leading cross-functional submission teams and successful regulatory submissions
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Excellent communication, leadership, and project management skills
Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
Up to 15 - 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless
The anticipated salary range for candidates for this role will be $220,000-$240,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A
pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here
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.
$220k-240k yearly Auto-Apply 45d ago
Regulatory Affairs Advertising and Promotional Reviewers
Canopy Life Sciences LLC
Remote job
Job Description At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team.
As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role.
This is a Remote position.
Responsibilities include:
Act as the primary Regulatory expert within an assigned clients Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs.
Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned products lifecycle.
Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate.
Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed.
Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned.
Qualifications for this position include:
At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review.
Ability to work independently in a remote role with minimal oversight.
Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities.
Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes.
Bachelors degree (advanced degree in a science discipline preferred)
As a part of our full-time team, you are eligible for our Comprehensive Benefits including:
Medical, Dental and Vision Insurance
Disability Insurance and Life Insurance
401(k) program with company match
A balanced approach to work-life that offers a generous PTO program and Holidays.
This is a remote position.
$83k-129k yearly est. 24d ago
Director - Strategic Regulatory Services (Secret Clearance Required)
RTX
Remote job
Country:
United States of America Hybrid
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Security Clearance:
DoD Clearance: Secret
RTX is an aerospace and defense company that provides advanced systems and services for commercial, military and government customers worldwide. It comprises four industry-leading businesses - Collins Aerospace Systems, Pratt & Whitney, Raytheon Intelligence & Space and Raytheon Missiles & Defense. Its 195,000 employees enable the company to operate at the edge of known science as they imagine and deliver solutions that push the boundaries in quantum physics, electric propulsion, directed energy, hypersonics, avionics and cybersecurity. The company, formed in 2020 through the combination of Raytheon Company and the United Technologies Corporation aerospace businesses, is headquartered in Arlington, VA.
The following position is to join our RTX Enterprise Services team:
Role Overview:
We are seeking a highly skilled, experienced, innovation-oriented and results-driven Director of Digital Strategic Regulatory Services (SRS) across the organization. This role is critical in ensuring the security, integrity, and resilience of our digital assets and information systems. The Director of SRS will be responsible for identifying and developing the implementation strategy for regulatory requirements across RTX (Domestic and International) to support the company's strategic objectives and operational effectiveness through delivery of efficient and effective compliance services.
The role will require a deep understanding of the regulatory landscape in aerospace and defense, the ability to lead through transformation, and successful partnership with key Enterprise functions. This role will evolve and lead an SRS program that is continuously monitoring and identifying new regulatory requirements and ensuring RTX is in the best position to comply.
The role requires and active Secret Clearance is order to be considered.
What You Will Do:
Define and implement a comprehensive global regulatory strategy that aligns with the company's strategic goals.
Ensures RTX global sites are compliant with digital policies, contractual requirements, and local regulations.
Strong understanding of global digital controls, risk management frameworks, standards, and best practices (e.g., Part-IS, ISO, NIS2, NIST, CMMC, GDPR, CIS, SCF).
Oversees the readiness of all unclassified Defense and Commercial systems for broad based assessment and certification including NIS2, Part-IS, ISO27001, AUS DISP, UK Cyber Essential/+, and CMMC, etc..
Inform, adopt and implement an operational strategy that leverages innovation and incorporates a Unified Controls Framework (UCF) across regulatory requirements to enable a test once use many approach to streamline assessments.
Define, implement, operate and report on key performance indicators (KPIs) and key risk indicators (KRIs) metrics related to SRS.
Lead the identification, assessment, prioritization and reporting of digital controls non-compliance risks across external assessments such as Part-IS, CMMC, DIBCAC, ISO, etc..
Lead and mentor a team of digital regulatory & controls professionals through transformation, fostering a culture of continuous improvement and innovation while inspiring to embrace RTX's core values
Collaborate with cross-functional teams, including IT, cybersecurity, audit, legal, and compliance, to ensure a cohesive approach to regulatory & policy testing and assessment.
Partner with other functions to drive the development and implementation of controls to safeguard digital assets and ensure compliance with industry standards and regulations.
Serve as a subject matter expert on digital regulatory & policy matters, providing guidance and support to business units and stakeholders.
Travel 25%.
Qualifications You Must Have:
A University Degree in Business, Science, Technology, Engineering or Mathematics and a minimum of 14 years of prior relevant experience, or an Advanced Degree in a related field and a minimum of 12 years of relevant experience.
Minimum of 12 years of experience in digital controls, cybersecurity, capability maturity or a related discipline, with at least 5 years in a leadership role.
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.
Qualifications We Prefer:
Preferably 5+ years of experience in a top-tier risk advisory or management consulting firm.
Proven track record of successfully managing digital controls programs in large, complex organizations, preferably within the Aerospace and Defense industries.
Ability to communicate with all levels of management verbally and written, facilitate effective meetings, build effective working relationships and partnerships, and strong interpersonal skills.
Excellent analytical, problem-solving, and decision-making skills.
Relevant certifications such as CISSP, CISM, CRISC, or similar are desirable.
Highly proficient in Microsoft Office products with experience in preparing presentations and presenting to executive leadership
Expert knowledge of national and international laws, regulations, policies, and ethics as they relate to cybersecurity (e.g., DFARS, FAR, ITAR, EAR, NIST 800-53, NIST 800-171)
General knowledge of IT, Artificial Intelligence, and cybersecurity with experience in the following areas: incident response, business continuity/ disaster recovery, vulnerability management, application security, database security, identity & access management, OT security, cloud security, third-party & supply chain risk management
What We Offer: Whether you're just starting out on your career journey or are an experienced professional, we offer a robust total rewards package with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care.
Learn More & Apply Now!
Work Location: Remote
Please consider the following role type definition as you apply for this role:
Remote: This position is currently designated as remote. However, the successful candidate will be required to work from one of the 50 U.S. states (excluding U.S. Territories). Employees who are working in Remote roles will work primarily offsite (from home). An employee may be expected to travel to the site location as needed.
The salary range for this role is 176,000 USD - 352,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is 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, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
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$98k-152k yearly est. Auto-Apply 60d+ ago
Senior Regulatory Affairs Expert, TSCA
Merck KGaA
Remote job
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
You will work closely with different functions within MilliporeSigma Life Science, including R&D, Production, Quality and others. Your focus will be on new chemical uses and submissions and ensuring ongoing compliance. Subsequently you will be involved in assessing changes and customer needs, where you will leverage your expertise in US chemicals regulations to drive innovation and ensure compliance You will use your excellent communication and partnering abilities to work closely with stakeholders across the organization to provide advice on regulatory execution strategies, implementing initiatives that support our commitment to sustainable practices.
Responsibilities:
* Stay up-to-date with the latest developments in TSCA with a technically advanced understanding of assessment methods as well as experience in advocacy.
* Collaborate with cross-functional teams to ensure ongoing compliance and supporting internal process changes.
* Provide strategic regulatory expert guidance and support to R&D, Production, and Product Management to ensure compliance with regulatory requirements.
* Represent the company in industry associations, working groups, and regulatory forums, fostering collaboration and driving sustainable and responsible change in assessment methods and chemical management practices.
This role is open to remote work within the U.S.
Who You Are
Minimum Qualifications:
* Master in Natural Sciences, PhD preferred.
* Min. 5 years of profound experience and expertise on TSCA PMN submissions.
* Extensive professional experience in US chemicals regulations, preferably gained from previous activities in an industrial company especially related to chemical assessments under TSCA.
* Excellent analytical and problem-solving skills, with the ability to interpret complex regulations and provide practical recommendations.
* Strong communication and interpersonal skills, with the ability to effectively collaborate across functions and engage with stakeholders e.g. through practical experience in managing moderate to complex interdisciplinary projects.
* Mastering the balancing act of independently driving complex topics forward, making decisions and taking controlled risks, while at the same time subordinating yourself to the larger vision and task as a member of a team.
Career Level:
* D -Professional (4-9 years)
Pay Range for this position: $98,100 - $168,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
Direct link to benefits site if the hyperlink no longer works: *********************************************
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$98.1k-168k yearly 17d ago
Director, Regulatory CMC (Remote)
Immuneering Corporation
Remote job
Job Description
About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development.
General Summary of Duties:
The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management.
A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player.
Specific Duties, may include but not be limited to the following:
· Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals.
· Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA.
· Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers.
· Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts.
· Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes.
· Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings.
· Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals.
· Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO's and consultants.
Desired Skills and Qualifications
· Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred.
· Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus.
· Proven track record of successful CMC submissions and approvals in the US and internationally.
· In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
· Strong leadership, communication, and project management skills.
· Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.
· Ability to work effectively in a collaborative, fast-paced environment.
Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available.
Physical Demands/ Working Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.
While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.
Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.
Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.
Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.
$97k-154k yearly est. 15d ago
Clinical Compliance Manager
Healthcare Services 4.1
Remote 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 Compliance Manager(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 Compliance Manager 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 46d ago
Manager, Political Affairs
Edison Electric Institute 4.2
Remote job
Job Description
WHO WE ARE
The Edison Electric Institute (EEI) is the association that represents all U.S. investor-owned electric companies. Our members provide electricity for more than 220 million Americans and operate in all 50 states and the District of Columbia. As a whole, the electric power industry supports more than 7 million jobs in communities across the United States.
EEI employees are required to work in office Monday-Thursday, and have the option to work remotely on Fridays.
KEY RESPONSIBILITIES OF THE MANAGER, POLITICAL AFFAIRS:
The Manager, Political and External Affairs plays a critical role in advancing EEI's federal political engagement strategy by supporting the Senior Director across three core areas: PAC fundraising, industry event management, and political programming.
The Manager serves as the internal lead for PowerPAC fundraising, driving engagement from member companies. The Manager collaborates closely with the PAC Steering Committee and EEI leadership to meet annual fundraising goals, manage the PowerPAC budget, track performance, and ensure full compliance with all reporting requirements. The Manager also produces treasurer's reports, maintains donor and disbursement records, and provides background materials to support contribution decision-making.
Other important responsibilities of the Manager, Political Affairs:
Support the Senior Director in executing PowerPAC's fundraising strategy, helping to engage all eligible groups and member companies to meet annual fundraising goals.
Assist in developing PAC campaigns, strengthening relationships, and identifying opportunities to expand PAC participation and visibility.
Assist in managing the PowerPAC budget, including tracking fundraising totals, monitoring financial activity, preparing candidate disbursements, and supporting PAC Steering Committee operations.
Prepare treasurer's reports and write detailed memos summarizing political background information, candidate assessments, and related analysis.
Play a central role in planning and executing EEI's major political and industry events, ensuring operational excellence and strategic alignment with EEI's advocacy objectives.
Provide operational, financial, and compliance support to the Senior Director, including processing invoices; coordinating with the General Counsel's office on contracts; and preparing materials for the semiannual LD-203 contributions report.
Administer the charitable PAC match program, ensuring accuracy and timely processing on behalf of EEI employees who contribute to PowerPAC.
REQUIRED & PREFERRED QUALIFICATIONS:
A bachelor's degree in Political Science, Communications, Public Policy, or a related field is required.
6-8 years of experience in PAC management, political fundraising, political operations, or planning high-level political or industry events is required.
Demonstrated ability to research, interpret, and analyze political trends and developments.
Exceptional written and verbal communication skills with experience drafting policy briefs, analytical reports, and background materials for senior leaders, elected officials, or policymakers.,
Strong technical and administrative skills, including proficiency with Office 365 and Microsoft Office applications, and the ability to learn internal accounting and budgeting systems.
Strong organizational skills and the ability to take initiative, manage competing priorities, and complete projects in a timely manner are essential.
Travel requirement: 10%.
COMPENSATION
The salary range for role is $80,000-125,000. Starting annual salary will be determined on individual qualifications. We offer a competitive benefits package that includes medical, dental, vision, 401k, paid time off, tuition assistance, wellness incentives and programs, transportation subsidy, and professional development opportunities. The role is eligible for a performance based bonus for the 2026 calendar year which is paid out the following March.
PHYSICAL AND SENSORY DEMANDS
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EEI is committed to providing a productive and safe environment. To achieve that goal, we conduct background and reference check investigations for all final applicants being considered for employment. Equal Opportunity Employment M/D/F/V.
$80k-125k yearly 12d ago
Director, Tax Provision & Compliance
Ciena 4.9
Remote job
As the global leader in high-speed connectivity, Ciena is committed to a people-first approach. Our teams enjoy a culture focused on prioritizing a flexible work environment that empowers individual growth, well-being, and belonging. We're a technology company that leads with our humanity-driving our business priorities alongside meaningful social, community, and societal impact.
We are seeking a Director to lead our tax provision and compliance team. This role involves leading the daily execution and ongoing development of both U.S. and foreign income tax provision and compliance processes. This position reports directly to the Senior Director, Global Tax and will collaborate closely with key internal partners from Tax, Controllership, Legal, Internal Audit, FP&A, and Treasury, to optimize tax structures, manage effective tax rates, optimize cash tax flows, ensure compliance with tax laws and filing requirements, minimize risks and tax exposures.
Responsibilities:
Own the preparation and review of the quarterly and annual tax provision in compliance with ASC 740, FIN 18, and other related standards.
Manage all aspects of global income tax reporting, including deferred tax assets/liabilities, valuation allowances, uncertain tax positions, and effective tax rate calculations.
Support documentation and tax research for income tax strategies, policies and positions
Support forecast modeling with respect to future effective tax rates and cash taxes in collaboration with FP&A
Oversee the preparation and filing of federal and state tax income tax returns.
Ensure timely and accurate return-to-provision reconciliation adjustments.
Partner with key teams to prepare tax disclosures for SEC filings (e.g., 10-K, 10-Q) and other financial statements.
Monitor and analyze legislative and regulatory changes, assessing their impact on the organization's tax positions and financial statements.
Lead process optimization initiatives, including evaluating and implementing tax technology tools for greater efficiency and accuracy.
Maintain SOX-compliant internal controls related to tax reporting and compliance.
Provide technical leadership and mentorship to tax staff, managing performance and fostering professional development.
Represent the tax team in discussions with external auditors, advisors, and relevant authorities as needed.
Manage, mentor, and develop a team of tax professionals to maximize their performance and career growth, fostering a culture of continuous learning and collaboration.
Support the business on ad-hoc tax inquiries and various non-income tax analyses and filings on an as-needed basis
Manage and oversee income tax audits and inquiries, working closely with external advisors and internal stakeholders to address and resolve issues.
About You
Experience:
12+ years of progressive tax experience, with expertise in ASC 740, SBC, Section 174, R&D tax credits and tax compliance.
Background in public accounting (Big 4 preferred) and/or corporate tax in a multinational public company.
Strong understanding of global tax compliance and reporting issues.
Education & Certification:
Bachelor's degree in Accounting, Finance, or related field required; CPA and/or MST (Master's in Taxation) strongly preferred.
Skills:
Demonstrated ability to lead high-performing teams and manage a large-scale tax provision and compliance function.
Expert-level knowledge of U.S. GAAP, international tax principles, and related reporting requirements.
Proven track record of process improvement, including the use of tax technology to drive efficiencies.
Ability to work under tight deadlines in a fast-paced, ever-changing environment.
Excellent analytical thinking, communication, and relationship-building skills.
Demonstrated ability of cultivating talent, fostering both technical excellence and interpersonal growth.
Positive attitude, enthusiasm, and team building skills
Pay Range:
USA: $173,600 - $ 250,400
Pay ranges at Ciena are designed to accommodate variations in knowledge, skills, experience, market conditions, and locations, reflecting our diverse products, industries, and lines of business. Please note that the pay range information provided in this posting pertains specifically to the primary location, which is the top location listed in case multiple locations are available.
Non-Sales employees may be eligible for a discretionary incentive bonus, while Sales employees may be eligible for a sales commission. In addition to competitive compensation, Ciena offers a comprehensive benefits package, including medical, dental, and vision plans, participation in 401(K) (USA) & DCPP (Canada) with company matching, Employee Stock Purchase Program (ESPP), Employee Assistance Program (EAP), company-paid holidays, paid sick leave, and vacation time. We also comply with all applicable laws regarding Paid Family Leave and other leaves of absence.
Not ready to apply? Join our Talent Community to get relevant job alerts straight to your inbox.
At Ciena, we are committed to building and fostering an environment in which our employees feel respected, valued, and heard. Ciena values the diversity of its workforce and respects its employees as individuals. We do not tolerate any form of discrimination.
Ciena is an Equal Opportunity Employer, including disability and protected veteran status.
If contacted in relation to a job opportunity, please advise Ciena of any accommodation measures you may require.
$173.6k-250.4k yearly Auto-Apply 4d ago
Carrier Compliance Manager - Remote US Based
Mode Global 4.2
Remote job
MODE Global is the 5th largest truckload broker and largest non-asset intermodal provider in North America. With over 200 agents/offices distributed from coast to coast, MODE Global operates under a family of businesses and brands, delivering as a premier full-service solutions provider to the logistics industry.
Job Title: Carrier Compliance Manager
Job Summary: The Carrier Compliance Manager plays a crucial role in ensuring that carriers (transportation companies) comply with all relevant regulations and standards governing their operations. This role involves developing and implementing compliance strategies, monitoring carrier activities, and maintaining up-to-date knowledge of regulatory changes. The Carrier Compliance Manager collaborates closely with internal teams and external stakeholders to uphold compliance and mitigate risks associated with transportation operations.
Responsibilities:
Develop and implement compliance policies and procedures for carriers in accordance with local, state, and federal regulations.
Conduct regular audits and inspections of carrier operations to ensure adherence to compliance standards.
Provide guidance and training to carriers on compliance requirements and best practices.
Monitor carrier performance metrics to identify areas for improvement and compliance gaps.
Investigate and address compliance violations, taking corrective actions as necessary.
Stay informed about changes in transportation regulations and industry trends and communicate updates to relevant stakeholders.
Collaborate with cross-functional teams, including operations, legal, and procurement, to address compliance-related issues and implement solutions.
Maintain accurate records and documentation related to carrier compliance activities.
Develop and maintain relationships with regulatory agencies and industry associations to stay abreast of regulatory developments and participate in industry initiatives.
Analyze data and trends to identify potential compliance risks and opportunities for process improvement.
Work with outside agencies, i.e. RMIS, SAFER, DOT, DOI to ensure proper regulatory compliance for carriers.
Take part in the hiring/training of new hires or re-training of internal staff.
Create SOPs, guidelines for staff to ensure proper vetting practices.
Working with Corporate Ops to prevent and maintain logs for Bad Actors and Double Brokering matters.
Participate in projects and Senior Leadership discussions regarding people and process management.
Have biweekly/monthly meetings with Compliance Leaders to ensure process management and share ideas on progression of Compliance management.
Qualifications
• 10 years in business administration, logistics, supply chain management, or a related field.
• Previous experience in transportation, logistics, or regulatory compliance preferred.
• Strong understanding of transportation regulations and compliance requirements.
• Excellent analytical skills and attention to detail.
• Effective communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite and other relevant software applications.
• Certification in transportation compliance or related field (e.g., Certified Transportation Professional) is a plus.
Expectations:
• The Carrier Compliance Manager is expected to demonstrate a high level of integrity and professionalism in carrying out their responsibilities.
• They should possess strong leadership skills and the ability to influence and drive compliance initiatives across the organization and with external partners.
• Additionally, the successful candidate should be proactive in identifying compliance risks and implementing effective solutions to mitigate them.
• The Carrier Compliance Manager should stay current with regulatory changes and industry best practices to ensure that the organization remains in compliance and operates efficiently.
• This role requires a commitment to continuous improvement and a willingness to adapt to evolving regulatory requirements and business needs.
Why MODE?
MODE Global is the 5th largest truckload broker and largest non-asset intermodal provider in North America. With over 200 agents/offices distributed from coast to coast, MODE Global operates under a family of businesses and brands, delivering as a premier full-service solutions provider to the logistics industry.
At MODE, we're dedicated to providing our employees with a working environment where they can flourish professionally and personally. You can expect an inclusive and supportive workplace where people help each other succeed. Our benefits package is exceptional, including medical, dental, and vision with flexible time off policies. We believe in the future of our employees, so we offer a generous match to your 401k plan. With locations all across the United States, you can join us in providing transportation and logistics solutions to our customers.
$66k-95k yearly est. 19d ago
Director of Governance, Risk and Compliance
Laserfiche 4.7
Remote job
Description Laserfiche is hiring a Director of Governance, Risk & Compliance (GRC) to lead enterprise-wide governance, risk and compliance programs at Laserfiche. This hands-on role will be responsible for ensuring the organization operates in alignment with regulatory compliance requirements, industry standards and internal policies, while enabling business agility and operational excellence. The ideal candidate has deep experience in cyber and physical security, IT risk management, business resiliency, AWS services and data privacy-along with hands-on involvement with implementing controls, standards and frameworks such as ISO 27001, NIST 800-53, FedRAMP/GovRAMP and SOC 2 controls (AICPA Trust Services Criteria). Location:
Hybrid: Three days per week (Tuesday, Wednesday and Thursday) in-office in Long Beach, CA
Remote work from home on Mondays and Fridays
Periodic travel including travel on weekends as needed for international site audits
About the Role - Key Responsibilities: Governance and Risk Management
Develop and lead the enterprise Governance, Risk and Compliance (GRC) program to ensure effective alignment between business objectives, risk management and regulatory compliance requirements.
Provide hands-on leadership for AI and security governance, cybersecurity controls (SOC 2, ISO 27001, GovRAMP/FedRAMP, CMMC, NIST 800-53, CJIS, PCI), data privacy and regulatory compliance (EU AI Act, GDPR, CCPA, PIPEDA, HIPAA).
Partner with technology and business leaders to assess AI, technology and security risks, and ensure appropriate controls are designed, implemented, tested and operating effectively.
Collaborate with ITS, Development and other departments to lead IT, security and business resiliency policy creation, maintenance, communication, training and enforcement across the enterprise.
Safeguard Laserfiche information in accordance with Laserfiche Information Security Policies.
Compliance & Controls Oversight and Monitoring
Own and lead compliance and certification programs (SOC 2, ISO 27001, ISO 42001, ISO 9001, GovRAMP/FedRAMP, CMMC) that are aligned to industry standards and regulatory frameworks.
Manage and conduct internal audits, risk assessments, third-party and vendor risk management assessments.
Coordinate control self-assessments, remediation and risk treatment plans.
Manage and update control matrices and risk registers; ensure controls are mapped to relevant frameworks and operating effectively.
Manage continuous controls monitoring and risk reporting provided to external and internal stakeholders.
Data Privacy
Partner with Legal, ITS, Development, People and other organizations to operationalize privacy requirements.
Oversee and perform data mapping and data inventory activities, ensuring accurate organizational understanding of data flows, risks and controls.
Collaborate with Legal and other departments on performing DPIA/PIAs and other compliance initiatives.
Business Resiliency and Disaster Recovery (DR)
Lead the business continuity management program, including performing an annual business impact analysis (BIA), developing, testing and updating BCPs, and providing organizational training in collaboration with L&D.
Coordinate with ITS on DR planning and testing, and working with executive stakeholders on updating and testing crisis management plans (CMP).
Customer Sales Enablement and Product Development
Collaborate with Sales, ITS, Development and Legal on sales enablement initiatives including responding to RFPs and customer questionnaires on security controls, data privacy, AI, BCM, DR and CMP.
Serve as a subject matter expert on internal controls and security, and collaborate with Product Strategy, Development and ITS on product enhancements, features and security capabilities.
Monitor Laserfiche security controls and compliance with customer contractual requirements.
About You - Essential Qualifications:
Bachelor's degree in management information systems, IT audit, cybersecurity or related degree program is required
Minimum of 7+ years of experience in information security, IT risk management, compliance, or related GRC disciplines.
Certification is required in a relevant area (e.g., CISA, CRISC, CISM).
Demonstrated leadership experience building or scaling enterprise GRC programs.
Experience with industry regulations (e.g., HIPAA, GDPR, CCPA), GovRAMP/FedRAMP, NIST standards (NIST 800-53), ISO 27001 certifications, SOC 2 reporting and security assessments, and leading frameworks such as AICPA Trust Services Criteria.
Strong understanding of privacy regulations and experience with operational privacy work (data mapping and flow diagramming, DPIAs, data governance).
Strong technical skills in cybersecurity, controls and AWS security audits; Big Four experience a plus.
Excellent communication, presentation and negotiation skills, with the ability to influence internal and external stakeholders and write policies and controls documentation.
Exceptional organizational and program management skills with a keen attention to detail.
Ability to thrive in a fast-paced environment with competing priorities and deadlines.
Ability to manage complex, cross-functional projects with internal and external stakeholders.
The salary range varies, and pay is based on several factors including but not limited to education, certifications (if applicable), candidate's geographic region, job-related knowledge, skills and years of experience amongst other factors.
$180,000 - $230,000 per year
Perks & Benefits at a Glance
Generous time off:
15 Days of Vacation
3 Floating Holidays
2 Paid Volunteer Days
9 Paid Holidays
Hybrid Work Environment
Free Parking: covered and EV charging stations
Various 401 (k) Investment Options and Generous Company Match
HMO and PPO Medical Care Options
Applicants must be authorized to work for Laserfiche in the United States on a full-time basis without the need for employer sponsorship. We are unable to sponsor new employment visas, or take over sponsorship of existing employment visas, at this time.
About Us
Laserfiche is a global leader in intelligent document management and business process automation, dedicated to helping organizations drive digital transformation. Headquartered in Long Beach, California, Laserfiche empowers businesses of all sizes-from dynamic startups to Fortune 500 enterprises-to accelerate productivity, improve collaboration, and deliver exceptional customer experiences.
Through scalable workflows, customizable digital forms, and AI-powered automation, the Laserfiche platform enables teams to simplify complex processes and operate with greater efficiency. Our no-code solutions empower employees to innovate, adapt quickly, and make data-driven decisions that move their organizations forward.
With a strong global presence and offices across North America, Europe, and Asia, Laserfiche is recognized for its commitment to innovation, quality, and customer success. Our people-first culture fosters professional growth, continuous learning, and collaboration-making Laserfiche a place where talented individuals can shape the future of digital enterprise technology.
Learn more about our team here.
Laserfiche complies with all Equal Opportunity and Affirmative Action regulations. Laserfiche makes all employment decisions - such as recruiting, hiring, training, promotion, compensation, professional development practices, discipline and termination - without regard to race, religion, color, national origin, ancestry, citizenship, sex, pregnancy, age, creed, physical or mental disability, medical condition, genetic characteristic, marital status, veteran status, gender identity/expression, sexual orientation or any other characteristic protected by law, except as may be permitted by law. Laserfiche provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Talent Acquisition at *********************************** or ************. Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, and the Los Angeles Fair Chance Initiative for Hiring Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, meet client expectations, standards, and accompanying requirements, and safeguard business operations and company reputation. #LI-Hybrid
$180k-230k yearly Auto-Apply 13d ago
Enterprise Leads Compliance Manager (Hybrid)
Globe Life Inc. 4.6
Remote job
Primary Duties & Responsibilities At Globe Life, we are committed to empowering our employees with the support and opportunities they need to succeed at every stage of their career. We take pride in fostering a caring and innovative culture that enables us to collectively grow and overcome challenges in a connected, collaborative, and mutually respectful environment that calls us to help Make Tomorrow Better.
Role Overview:
Could you be our next Leads Compliance Manager? Globe Life is looking for an Leads Compliance Manager to join the team!
In this role, you will be responsible for establishing and maintaining compliance standards for all sales lead-related activities across the enterprise, including, but not limited to lead sourcing, storage, distribution, and usage, vendor partnerships, and vendor marketing practices. This role serves as the subject matter expert for sales lead-related compliance requirements across the enterprise. The position requires extensive cross-collaboration with internal/external Legal, Compliance, and Privacy Teams to execute comprehensive compliance initiatives and maintain regulatory standards.
This is a hybrid position located in McKinney, Texas (WFH Monday & Friday, In Office Tuesday-Thursday).
What You Will Do:
* Develop and maintain lead compliance policies, procedures, and playbooks for sales leads across the enterprise
* Conduct periodic audits and ongoing reviews to identify compliance gaps and partner with vendors and internal teams to remediate findings.
* Partner with internal teams to help ensure adherence to data privacy requirements and consumer protection standards (TCPA, DNC, CAN-SPAM, CCPA, federal and state insurance regulations, and other applicable laws) across all lead channels
* Conduct regular compliance assessments and risk evaluations of lead sources
* Investigate and help resolve compliance violations and/or consumer complaints
* Partner with internal teams and third-party vendors (where applicable) to provide compliance training and guidance to sales leadership, sales agents, and ELG vendor management team
* Maintain proper documentation and reporting for regulatory examinations and/or audits
* Collaborate extensively with Legal, Compliance, Privacy, and other internal teams to design and implement compliance controls and initiatives
* Coordinate cross-functional compliance projects and serve as liaison between business units and regulatory teams
* Stay current on evolving regulations and industry best practices
* Manage vendor compliance certifications and contract requirements
* All other duties as assigned
What You Can Bring:
* Bachelor's degree in Business, Legal Studies, or related field
* 3-5 years of compliance experience, preferably in insurance or financial services
* Experience with lead generation, digital marketing compliance, and/or vendor management
* Experience with compliance monitoring software and tools
* Strong knowledge of telemarketing regulations (TCPA, DNC, etc.) and consumer protection/data privacy regulations (CCPA, GDPR, etc.)
* Proven ability to collaborate effectively across multiple departments and functional areas
* Experience working with Legal, Compliance, and Privacy teams on regulatory initiatives
* Excellent analytical and problem-solving skills
* Strong written and verbal communication abilities
* Detail-oriented with ability to effectively manage multiple projects simultaneously
* Strong project management skills with ability to coordinate cross-functional initiatives and document statuses/results
* Strong knowledge of telemarketing regulations (TCPA, DNC, etc.) and consumer protection/data privacy regulations (CCPA, GDPR, etc.)
* Certifications preferred, but not required:
* Certified Insurance Marketing Specialist (CIMS)
* Certified Insurance Compliance Manager (CICM)
* Associate, Insurance Regulatory Compliance (AIRC)
* Accredited Insurance Compliance Professional (AICP)
Applicable To All Employees of Globe Life Family of Companies:
* Reliable and predictable attendance of your assigned shift.
* Ability to work full time and/or part time based on the position specifications.
How Globe Life Will Support You:
Looking to continue your career in an environment that values your contribution and invests in your growth? We've curated a benefits package that helps to ensure that you don't just work, but thrive at Globe Life:
* Competitive compensation designed to reflect your expertise and contribution.
* Comprehensive health, dental, and vision insurance plans because your well-being is fundamental to your performance.
* Robust life insurance benefits and retirement plans, including company-matched 401k and pension plan.
* Paid holidays and time off to support a healthy work-life balance.
* Parental leave to help our employees welcome their new additions.
* Subsidized all-in-one subscriptions to support your fitness, mindfulness, nutrition, and sleep goals.
* Company-paid counseling for assistance with mental health, stress management, and work-life balance.
* Continued education reimbursement eligibility and company-paid FLMI and ICA courses to grow your career.
* Discounted Texas Rangers tickets for a proud visit to Globe Life Field.
Opportunity awaits! Invest in your professional legacy, realize your path, and see the direct impact you can make in a workplace that celebrates and harnesses your unique talents and perspectives to their fullest potential. At Globe Life, your voice matters.
Location: McKinney, TX
$84k-101k yearly est. 18d ago
Director, Governance, Risk & Compliance
Next Gen 3.6
Remote job
The Director, Governance, Risk & Compliance leads a team of analysts to build and maintain an effective GRC program at NextGen Healthcare. The ideal candidate will collaborate closely with the rest of the Information Security department, along with Product, R&D, and Engineering teams to define and partner on appropriate security controls across NextGen products and systems, including NextGen SaaS offerings and platforms. This team will also have responsibility for NextGen Healthcare's Security Governance and various regular Certification cycles and partnering with Legal on Information Security related contracts and requirements.
Establish IT audit procedures relevant to HITRUST/HIPAA, ISO 27001, SOC 2, and other data protection or privacy-related regulations
Provide governance and security oversight around the company's adoption and use of AI, LLMs, and other generative-AI capabilities
Evaluate and test the design and operating effectiveness of technical and administrative security controls
Maintain and manage the Third-Party Risk Management program and integration with Vendor and Customer related Security obligations, requirements, and contractual agreements
Work closely with the CISO to develop and implement strategies for governance and compliance related to corporate-wide security initiatives
Design and implement data protection policies, process and procedures to align with HIPAA and Information Security policies, especially for cloud-hosted data environments and customer data handling throughout the development lifecycle
Implement and manage an Identity Governance Program to ensure appropriate authorization to key resources, including the development of a Role Based Access Control and Role Review process.
Develop training programs and FAQs related to data protection, privacy and secure data handling procedures
Provide oversight and guidance for periodic security assessments to ensure compliance with information security policies and established security controls
Develop metrics and compliance dashboards to measure progress for security initiatives and communicate team accomplishments and the effectiveness of audited security controls and processes
Maintain and mature the Risk Register, Policy Exception Tracking, and Security Dashboard processes, standards, and components
Ensure applications, networks, systems, cloud services, people, and process are assessed, monitored and audited in accordance with security controls related to SOC 2, ISO 27001, HITRUST/HIPAA and the corporate Information Security Policy
Work closely with cross-functional teams to ensure security controls have been designed effectively and are working as intended
Identify control deficiencies and weaknesses and recommending remediation plans for improvements
Create, manage and hold staff accountable for corrective action plans (CAPs)
Implement a process for continuous improvement of IT controls
Work with internal and external resources to conduct and manage an assessment program for compliance requirements, including auditing and monitor privileged access to critical information systems; authentication and authorization processes; change control processes and IT operations processes
Work closely with the Engineering teams to automate monitoring and auditing to reduce manual effort required for compliance activities
Develop communication plans for executive-level reporting
Lead the team in the development and evolution of security roadmaps, embodiment of strategic plans, understanding controls and process gaps, providing architectural vision, and enabling the larger information security team.
Hire, grow and retain team members to expand the team and its capabilities within the organization.
Perform assessments of security tools, vendors, and solutions to support information security roadmap initiatives
Act as an advocate for mentoring and technical career growth in the information security organization
Act as a liaison with other internal NextGen teams or driving new capabilities, product investments, and research to fill coverage gaps.
Provide assistance and guidance to Sales and Support teams across various customer engagements.
Regularly provide key performance and risk indicator metrics for management visibility into the status, health, and maturity of the Information Security Program at NextGen.
Education Required:
Bachelor's degree in Computer Science, Programming, Engineering, or similar field.
Or, any combination of education and experience which would provide the required qualifications for the position.
Experience Required:
4+ years of experience in Information Security with an emphasis on IT audit, IT risk management and/or IT compliance.
Prior experience with managing a GRC team.
Extensive background in information security services and operations and the people, process, and technology components.
Significant experience in fulfilling business needs through the development of solutions through well-organized processes.
Experience in client-facing discussions with new and existing customers to discuss security controls and implementations.
Significant Service Management and or vendor management experience.
License/Certification Required:
Appropriate certifications a plus.
Knowledge, Skills & Abilities:
Knowledge of: Knowledge of technical security control environments and compliance frameworks including CSA CCM, ISO 270001 and SOC 2, HITRUST/HIPAA and GDPR.
Skill in: Excellent analytical, technical and internal audit skills. Excellent organizational and documentation skills. Strong project management skills highly desired.
Ability to: Proven ability to manage priorities & deadlines and to work independently in a highly dynamic and diverse environment with multiple concurrent projects happening simultaneously.
The company has reviewed this to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
NextGen Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
$74k-106k yearly est. Auto-Apply 18d ago
Director, Cold Chain Management & GDP Compliance
Biomarin Pharmaceutical 4.6
Remote 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, FinanceExternal 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.
$115k-144k yearly est. Auto-Apply 60d+ ago
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Amgen 4.8
Remote job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Live
What you will do
Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen's GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 5 years of regulatory experience in biotech or science
OR
Master's degree and 8 years of regulatory experience in biotech or science
OR
Bachelor's degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications:
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#Obesity
.
Salary Range
216,805.00 USD - 259,624.00 USD
$100k-131k yearly est. Auto-Apply 60d+ ago
Director, Fintech Compliance
Toast 4.6
Remote 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 compliance management 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 managing compliance team supporting Fintech products.
Oversee the development and maintenance of product-specific compliance management programs within Toast's Fintech Line of Business. Direct the Fintech Compliance team on establishing best-in-class compliance management 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
How Toast Uses AI in its Hiring Process
Throughout the hiring process, our goal is to get to know you. We use AI tools to support our recruiters and interviewers with tasks like note-taking, summarization, and documentation of interviews to ensure they can be fully focused on your conversation. All hiring decisions are made by people.
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: *********************************************
Apply today!
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 4d ago
Learn more about regulatory compliance director jobs