Regulatory Affairs Associate remote jobs - 135 jobs
Remote Regulatory Affairs Consultant (Strategy)
Pharmatech Associates 3.6
Remote job
A leading consulting firm in regulatory affairs is seeking a Regulatory Affairs Consultant to work remotely, supporting ongoing projects with 10-20 hours per week. You will lead the development and execution of regulatory strategies, engage with the FDA, and provide guidance throughout product development. The ideal candidate will have an advanced degree in science or biomedical engineering and a minimum of 10 years of experience in regulatory applications. Join a diverse and inclusive team dedicated to impactful work.
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$72k-102k yearly est. 3d ago
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Manager, Regulatory Affairs - Hybrid - 134458
University of California San Diego 4.6
Remote job
#134458 Manager, Regulatory Affairs - Hybrid
will remain open until a successful candidate has been identified.
This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.
DESCRIPTION
The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership that brings together UC San Diego, San Diego State University, and the La Jolla Institute of Immunology to advance cancer research and care.
Reporting directly to the Executive Administrative Director of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators and takes on key programmatic responsibilities to strengthen regulatory practices across the clinical research organization.
The incumbent demonstrates expertise in regulatory matters, serves as a subject matter expert when engaging with sponsors and auditors, and designs large‑scope, high‑complexity research projects that drive the MCC CTO's overall success.
Managing a team of highly skilled professionals in a matrixed organization, the Regulatory Manager ensures the achievement of the MCC CTO's activation targets and ongoing compliance with regulatory requirements for all active clinical trials under the CTO's purview.
Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. Provide direction on programmatic efforts and developing systems to streamline regulatory processes in a compliant manner.
MINIMUM QUALIFICATIONS
Nine years of related experience, education/training, OR a Bachelor's degree in related area plus five years of related experience/training.
Clinical Trial Professional certification from a professional society within one year in position.
Broad knowledge of clinical or laboratory research and clinical research philosophy; demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.
Demonstrated project management skills; ability to effectively manage multiple priorities and meet the demands of a fast‑paced and dynamic work environment.
Demonstrated experience managing people with a wide range of educational backgrounds and skills; demonstrated management and conflict resolution skills to effectively lead and motivate others.
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
Excellent interpersonal skills, including problem‑solving, teamwork development, leadership, mentorship, and ability to cultivate relationships with multiple stakeholders at various levels of administration.
Proficiency with word processing, spreadsheet software, clinical trial management systems, and clinical information and documentation application programs.
Collaboration skills to interface and coordinate with cross‑functional teams and influence and persuade in program integration.
PREFERRED QUALIFICATIONS
Advanced degree.
PAY TRANSPARENCY ACT
Annual Full Pay Range: $97,200 - $182,000 (will be prorated if the appointment percentage is less than 100%). Hourly Equivalent: $46.55 - $87.16.
EQUAL OPPORTUNITY EMPLOYER STATEMENT
The University of California 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, disability, age, protected veteran status, or other protected status under state or federal law.
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$97.2k-182k yearly 2d ago
Remote Regulatory Affairs Manager - Global Submissions Lead
Crinetics Pharmaceuticals, Inc. 3.9
Remote job
A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance.
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$85k-126k yearly est. 1d ago
US Regulatory Affairs Specialist
Henry Schein 4.8
Remote job
This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance.
KEY RESPONSIBILITIES:
Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company's ongoing compliance with Federal, State and local requirements.
Initiate and maintain medical device product registrations globally, focusing on international markets.
Support the development of Regulatory strategies and processes.
Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.
Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.
Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Determine and communicate submission and approval requirements
Participate in risk benefit analysis for regulatory compliance
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Provide support during inspections and formulating the appropriate response and corrective actions
Assist compliance with product post marketing approval requirements
Review regulatory aspects of contracts
Assist with label and Instructions for Use (IFU) development and review for compliance before release
Ability to manage multiple establishment and product registration activities
Submit and review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications
Other duties as assigned.
SPECIFIC KNOWLEDGE & SKILLS:
2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.
Experience with FDA pre-market submissions preferred.
Experience with ISO 13485 and EU MDR preferred
GENERAL SKILLS & COMPETENCIES:
Good understanding of industry practices
Proficient with tools, systems, and procedures
Basic planning/organizational skills and techniques
Good decision making, analysis and problem solving skills with ability to multi-task
Good verbal and written communication skills
Good presentation and public speaking skills
Good interpersonal skills
Basic conflict resolution skills
Developing professional credibility
MINIMUM WORK EXPERIENCE:
Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.
PREFERRED EDUCATION:
Typically a Bachelor's Degree or global equivalent in related discipline.
TRAVEL / PHYSICAL DEMANDS:
Travel typically less than 10%. Office environment. No special physical demands required.
The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.
This position is eligible for a bonus not reflected in the posted range.
Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
For more information about career opportunities at Henry Schein, please visit our website at: ***************************
Fraud Alert
Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment.
Please be advised that Henry Schein's official U.S. website is
*******************
. Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal.
No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.
$61.8k-85k yearly Auto-Apply 20d ago
Senior Regulatory Specialist - Cosmetics / Personal Care, Remote
Clorox 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
Your role at Clorox:
The Senior Regulatory Specialist will serve as a strategic regulatory partner for the Burt's Bees business, supporting product development, commercialization, brand maintenance, implementation of regulatory best practices, and maintaining a robust compliance program for our personal care and over-the-counter (OTC) drug products.
This role independently leads regulatory activities, ensuring compliance with global regulations while enabling innovation and speed to market.
Daily cross-functional collaboration is essential, involving teams across Product Safety & Regulatory Affairs (PS&RA), Product Development, Legal, Corporate Quality, Marketing, and Government Affairs.
Through this work, you will play a key role in accelerating profitable growth, driving structural margin expansion, and unlocking value through transformation.
This job will be a fully remote position based in the United States.
In this role, you will:
Regulatory Strategy & Project Leadership
Independently represent the PS&RA function on cross-functional project teams, ensuring regulatory compliance and timely project execution.
Develop and execute regulatory strategies for cosmetics, personal care, and OTC products, ensuring alignment with business goals.
Analyze and interpret regulatory data to provide strategic recommendations and influence project direction.
Identify regulatory risks and mitigation strategies to support successful product launches.
Maintain and update State and Federal reporting requirements related to your project categories (e.g., California Safe Cosmetics SB 312, CDER, Cosmetics Direct).
Documentation & Communication
Prepare and review regulatory documentation including but not limited to ingredient assessments, formula reviews, product dossiers, claims, packaging labels, marketing communication materials.
Translate complex regulatory and technical information into clear, actionable guidance for internal stakeholders.
Effectively communicate with internal teams and external partners, including regulatory authorities and industry groups.
Contribute to the development and implementation of effective documentation and data control management for compliance files within the Regulatory Information Management System.
Cross-Functional Collaboration
Lead cross-functional collaboration with R&D, Legal, Quality, and Marketing teams.
Provide regulatory guidance throughout the product lifecycle, from concept to commercialization.
Mentor junior team members and contribute to building regulatory capability across the organization.
External Engagement & Best Practices
Represent the company in external forums, including trade associations and regulatory working groups.
Define and teach regulatory best practices within the team and broader organization.
What we look for:
Required Qualifications & Skills
Bachelor's degree in scientific discipline (e.g., Cosmetic Science, Chemistry, Biology, Toxicology).
7+ years of regulatory experience in the CPG industry, with 3+ years specifically in the cosmetic and personal care space.
Strong knowledge of FDA regulations [e.g., The Food Drug and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia markets), and OTC drug regulations/monographs.
Proven ability to lead project regulatory strategies and influence cross-functional teams.
Excellent written and verbal communication skills.
Results driven: Excellent operational skills including planning, organization and attention to detail.
Ability to develop effective solutions to diverse and complex business problems.
Desired Qualifications
Experience with natural products and botanical ingredients.
Knowledge of ISO 16128 (Natural and Organic Cosmetic Ingredients and Products).
Familiarity with sustainability and clean beauty standards.
#LI-Remote
Workplace type:
This position 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.
$106.7k-204.9k yearly 4d ago
Global Regulatory Affairs - CMC Talent Community
Telix Pharmaceuticals
Remote job
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities
Telix is always looking to connect with great talent in the market! While we may not have the position you're looking for open today, we'd love for you to share your information with us for future openings. This post is not for a specific role or territory, but we can reach out when an opening comes available.
See Yourself at Telix
The Global Regulatory CMC team is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. This team will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.
Key Accountabilities
Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
Education and Experience
Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3.
Interested in joining our mission?
Submit your information and let's stay connected!
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR PRIVACY POLICY HERE
$58k-86k yearly est. Auto-Apply 3d ago
Regulatory and Government Affairs - Associate Director (NY / Remote)
KBRA 3.7
Remote job
Regulatory and Government Affairs - Associate Director (NY / Remote)
Entity: KBRA Holdings LLC
Employment Type: Full-Time
Location: New York, New York or Remote (Remote only in CA, CO, DC, FL, IL, MD, NJ, MA, NY, PA, SC, TX, VA)
Summary:
KBRA's Regulatory and Government Affairs team is seeking a highly motivated Associate Director to support the firm's engagement with regulators, policymakers, and industry stakeholders. This position offers a unique opportunity to participate in conversations at the intersection of financial regulation, capital markets, and public policy.
The Associate Director will assist in monitoring regulatory and legislative developments, conducting policy research, and preparing materials for internal and external audiences. This position is ideal for candidates who have studied Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field and who have demonstrated experience in applying their research and analytical skills to real-world regulatory and policy issues.
About the Job:
Regulatory and Legislative Monitoring: Track and summarize relevant legislative, regulatory, and policy developments affecting credit rating agencies and the broader financial services sector.
Policy Research and Analysis: Conduct in-depth research and draft analyses on key policy areas such as capital markets regulation, financial stability, ESG disclosure frameworks, and credit ratings oversight.
Briefing Materials: Prepare policy briefs, internal memoranda, issue summaries, and talking points for senior leadership ahead of meetings with regulators, trade associations, and policymakers.
Stakeholder Engagement: Support and participate in preparation for policy roundtables, industry consultations, and conferences involving government or regulatory representatives.
Cross-Functional Collaboration: Work closely with teams across KBRA including Legal, Compliance, and Communications to maintain consistent and informed policy messaging.
Special Projects: Contribute to strategic initiatives related to regulatory trends, public policy priorities, and global coordination efforts.
You will be successful in this role if you possess:
Bachelor's or Master's degree in Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field.
Minimum four years of experience in financial regulation, public policy, or government affairs.
Excellent research, writing, and analytical skills, with the ability to distill complex policy issues clearly and accurately.
Strong organizational skills and attention to detail, and ability to manage multiple projects simultaneously.
Ability to work both independently and collaboratively in a fast-paced professional environment.
Proficiency with Microsoft Office Suite; familiarity with legislative tracking tools, regulatory databases, or financial market research platforms is a plus.
Familiarity with Generative AI tools such as ChatGPT for research, data insights, and general productivity is a plus.
What You will Gain:
Direct exposure to the regulatory and policy landscape shaping the global credit rating industry.
Opportunities to work with KBRA's experienced regulatory and government affairs professionals on meaningful policy issues.
Insight into how a leading credit rating agency engages with regulators, legislators, and industry bodies.
A deep understanding of how regulatory policy impacts capital markets and credit analysis.
Skill development in policy analysis, stakeholder engagement, and cross-functional collaboration.
A collaborative and mission-driven culture that values independence, integrity, and analytical excellence.
Salary Range:
The anticipated annual base salary range for this full-time position is $120,000 - $150,000. Offer amounts are determined by factors such as experience, skills, geography, and other job-related factors.
Benefits:
A flexible hybrid work schedule - Tuesdays, Wednesdays, Thursdays in the office
Competitive benefits and paid time off
Paid family and disability leave
401(k) plan, including employer match (100% vested)
Educational and professional development financial assistance
Employee referral bonus program
About Us:
KBRA is a full-service credit rating agency registered in the U.S., the EU and the UK, and is designated to provide structured finance ratings in Canada. KBRA's ratings can be used by investors for regulatory capital purposes in multiple jurisdictions.
More Info:
KBRA encourages applications from all qualified individuals without regard to race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, marital status, citizenship, disability, and veteran status or any other basis prohibited by federal, state or local law.
#LI-KS1
#Remote
$120k-150k yearly Auto-Apply 8d ago
Global Head of Regulatory Affairs
VM Agritech Inc.
Remote job
Job DescriptionBenefits:
Health insurance
Paid time off
Stock options plan
Vision insurance
Reports To: CEO Employment Type: Full-Time About VM Agritech (VMA)
At VM Agritech, we develop science-driven products that protect the health of plants, people, and soil. Our innovations deliver powerful results without compromising what matters. We provide solutions that are effective against pathogens and supportive of healthier plants, people, and ecosystems.
Position Summary
The Global Head of Regulatory Affairs is a key role within the growing global business at VMA. VM Agritechs first core products, Curezin and MiCure have received regulatory clearance in the USA, and we now need to obtain regulatory clearance for these and other new products around the world.
Were looking for an experienced Executive with hands-on experience of the global regulatory environment for agricultural products. The Executive will be responsible for identifying and working with Regulatory Consultants around the world to obtain timely approval for VMAs products and all regulatory filings worldwide.
Key Responsibilities
Reporting to CEO
The regulatory obligations of an agrochemical company are considerable; VMAs Regulatory Affairs (RA) will be responsible for and the head of RA will be VMAs penultimate authority on:
Adherence to FIFRA and 50 US state-level FIFRA equivalents
documentation
submission
maintenance / vigilance / audits
Compliance with 50 US state-level administrators for fertilizer and adjuvant registrations, and tonnage reporting {documentation}
submission
maintenance / vigilance / audits
Responsible for all aspects of the regulatory process and interaction with regulators globally
Key Executive in the decision process for timing and type of market access by country/region
Qualifications
Demonstrated understanding of the global regulatory environment at a granular level
High level academic background, ideally in an agricultural biology or chemistry specialization
Interacted with regulators and senior Governmental officials
Run consultants and a team of people to execute regulatory strategy.
Based either in the USA or Europe. Prepared and able to travel extensively given the nature of the role.
Benefits
Highly Competitive salary
401(k) with company match
Fully company-paid health, dental, and vision insurance
Flexible work arrangements and paid time off (PTO)
Stock options
Fully remote position
This is a remote position.
$58k-85k yearly est. 5d ago
Senior Regulatory Affairs Specialist (Remote - United States)
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:
Senior Regulatory Affairs Specialist
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 Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US. This role will support on-going product compliance throughout the device's lifecycle allowing you the opportunity to build strong relationships with stakeholders and management.
In this role, 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:
Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.
Managing complex decision-making among cross‑functional stakeholders in an area of regulatory that is complex and evolving.
Participating in global business and functional strategic meetings and forums representing regulatory affairs.
Performing regulatory assessments and determining registration plans with the business for strategic implementation.
Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained.
Acting as the focal point for commercial support pertaining to all regulatory activities.
Managing regulatory systems and tools to drive operational excellence for effective data tracking and to ensure regulatory data integrity.
Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization.
Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
Supporting any other duties within the role or tasks assigned from time to time.
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 (completed and verified) from an accredited institution AND five (5) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
OR
High School Diploma/GED (completed and verified prior to start) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment
In addition to the above requirements, the following are also required:
Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions
Additional qualifications that could help you succeed even further in this role include:
Advanced degree in Scientific, Engineering or Regulatory/Quality.
Experience supporting 13485 and MDSAP audits.
New Product Introductions (NPI) experience.
Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions.
Work location:
Remote in the United States
Travel: May include up to 10% domestic/international
Relocation Assistance: Is 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 $131,750 - $170,500, 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.
$131.8k-170.5k yearly Auto-Apply 5d ago
Senior Regulatory Affairs Specialist (Remote - United States)
Solventum
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:
Senior Regulatory Affairs Specialist
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 Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US. This role will support on-going product compliance throughout the device's lifecycle allowing you the opportunity to build strong relationships with stakeholders and management.
In this role, 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:
Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.
Managing complex decision-making among cross‑functional stakeholders in an area of regulatory that is complex and evolving.
Participating in global business and functional strategic meetings and forums representing regulatory affairs.
Performing regulatory assessments and determining registration plans with the business for strategic implementation.
Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained.
Acting as the focal point for commercial support pertaining to all regulatory activities.
Managing regulatory systems and tools to drive operational excellence for effective data tracking and to ensure regulatory data integrity.
Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization.
Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
Supporting any other duties within the role or tasks assigned from time to time.
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 (completed and verified) from an accredited institution AND five (5) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
OR
High School Diploma/GED (completed and verified prior to start) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment
In addition to the above requirements, the following are also required:
Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions
Additional qualifications that could help you succeed even further in this role include:
Advanced degree in Scientific, Engineering or Regulatory/Quality.
Experience supporting 13485 and MDSAP audits.
New Product Introductions (NPI) experience.
Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions.
Work location:
Remote in the United States
Travel: May include up to 10% domestic/international
Relocation Assistance: Is 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 $131,750 - $170,500, 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.
$131.8k-170.5k yearly Auto-Apply 5d ago
Regulatory Affairs Coordinator - Cancer Center Compliance (Remote)
Mayo Clinic Health System 4.8
Remote job
Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.
Benefits Highlights
* Medical: Multiple plan options.
* Dental: Delta Dental or reimbursement account for flexible coverage.
* Vision: Affordable plan with national network.
* Pre-Tax Savings: HSA and FSAs for eligible expenses.
* Retirement: Competitive retirement package to secure your future.
Responsibilities
Responsible for planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents (drugs, biologics, device, etc.). Monitors the internal and external regulatory environment to promote centralized, coordinated, and proactive identification, development, and implementation of new or revised policies, procedures, etc. applicable to MCCC research programs. Researches relevant regulatory issues and evaluates the adequacy and effectiveness of compliance processes and controls related to Mayo Clinic Cancer Center (MCCC) research programs. Proposes compliance-enhancing recommendations to MCCC leadership and facilitates the development and implementation of new or revised MCCC policies and procedures pertaining to human research protections and the investigational use of agents. Through these activities, facilitates, the compliance of MCCC research programs with Mayo Foundation and National Cancer Institute (NCI) policies, and U.S. and foreign government regulations, including those of the U.S. Food and Drug Administration, Health Canada, and other equivalent agencies. Participates in other compliance-related administrative activities including development and delivery of educational programs, and assistance, as necessary, during select external audits and site visits (i.e., FDA, and NCI or other sponsors). Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs. Represents the MCCC research programs from a regulatory perspective in national forums/venues. Presentations at meetings or other conferences, seminars, and classes, and occasional travel may be required. Manages the submission and ongoing maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Health Canada Clinical Trials Applications (CTAs), and other equivalent activities as may be applicable to the research programs of the MCCC. Supports the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office, and promotes efficiency and adaptability through the coordinated development and maintenance of policies, working instructions, standard operating procedures, protocol templates, etc., related to the protection of human subjects and investigational use of agents (drugs, biologics, etc.). May have direct supervisory responsibilities.
Qualifications
A bachelor's degree (BA,BS) and a minimum of 5 years' experience in compliance, quality management, audit, or other relevant healthcare experience is required. Typical duration of prior experience is 5-10 years. Knowledge and experience in the interpretation and application of laws and regulations relating to human subjects' research protections and investigational use of agents (drugs, biologics, etc.) are required. Exceptional human relations skills and excellent communication skills (written, verbal, and listening) are required. Organizational project management skills are essential. Should have an inquiring, analytical and persistent disposition to enable the asking of follow-up questions that might not occur to others and look deeply into each area of concern. Collaborates with management in identifying improvement opportunities and developing corresponding solutions. Must be flexible and capable of adapting to and facilitating change. Must be very detail oriented. Must have the ability to work independently and productively with a minimum of direction and to routinely exercise initiative and sound judgment. Must possess effective leadership and management qualities, including the ability to motivate and to influence others. Compliance issues may create difficult situations for the involved individuals. Therefore, fairness in approach is essential. Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for individuals. Computer literacy and medical terminology are essential. Must be efficient in the use of personal computers for word processing, spreadsheets, data analysis, creation of graphs and charts, presentations, electronic communications, and research. Must have demonstrated the capacity to comprehend complex structures and connections. The ability to exercise good judgment in ambiguous situations while under pressure; strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. A strong understanding of FDA regulations and proficiency in medical terminology is preferred.
The following certifications are preferred: Cert Clinical Res Professional (CCRP), Cert Clinical Research Assoc (CCRA), Certified Clinical Research Co (CCRC) and Regulatory Affairs Certificate (RAC) and Certified IRB Professional (CIP).
Note: Visa sponsorship is not available for this position. Must be a U.S. citizen, permanent resident, refugee or asylee.
Exemption Status
Exempt
Compensation Detail
$74,422.40 - $111,696.00 / year; Education, experience and tenure may be considered along with internal equity when job offers are extended.
Benefits Eligible
Yes
Schedule
Full Time
Hours/Pay Period
80 hrs
Schedule Details
Monday through Friday 8 am - 5 pm
Weekend Schedule
N/A
International Assignment
No
Site Description
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.
Equal Opportunity
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the 'EOE is the Law'. Mayo Clinic participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.
Recruiter
Stephanie Baird
$74.4k-111.7k yearly 2d ago
Regulatory Affairs Senior Specialist
MWI Animal Health
Remote job
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.
This role will provide accountability for the execution of operational tasks in the Regulatory practice area. This is a remote based role in the United States.
Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients.
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications.
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files.
Coordinates regulatory fee payments on behalf of client.
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence).
Liaises with regulatory authorities on behalf of clients (e.g., US Agent).
Builds, develops and maintains working relationships with clients.
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner.
Performs basic document management tasks including file transfer, storage, tracking, and archival.
Maintains familiarity with current global regulatory submission standards as well as departmental procedures.
Other duties as assigned.
Education:
Bachelor's Degree and 3-5 years' experience in Regulatory Affairs; or equivalent combination of education and experience.
Experience:
Experience working in the pharmaceutical industry.
Ability to prioritize and drive multiple projects.
Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines.
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA.
Ability to maintain confidentiality and responsive to client needs.
Ability to adapt under regularly changing conditions.
Outstanding organization, analytical, and problem-solving skills.
Excellent written, verbal and presentation communication skills.
Skills:
High attention to detail.
Technical writing capabilities
Experience in Microsoft Office as well as regulatory systems (e.g., document management systems, RIM systems etc.)
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
Full time
.
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Accessibility Policy
AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
Salary Range*Affiliated Companies:Affiliated Companies: PharmaLex US Corporation
$58k-84k yearly est. Auto-Apply 3d 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 29d ago
Sr. Regulatory Affairs Specialist - REMOTE
Jobgether
Remote job
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist. In this role, you will support the development and implementation of long-range regulatory strategies that impact the introduction of new products and the compliance of existing ones. Your leadership will guide regulatory staff, ensuring all products meet U.S. and international standards. You will be a key player in compliance activities and bear significant responsibility in product development and modifications.Accountabilities
Maintain current knowledge of applicable laws and regulations.
Interpret regulatory requirements for products and ensure compliance.
Participate as a regulatory representative on project teams.
Lead submission activities for device clearances/approvals.
Review change orders and assess regulatory impact.
Oversee labeling, training, and promotional material compliance.
Represent the organization in working groups related to regulatory objectives.
Support due diligence and post-acquisition assessments.
Develop and implement regulatory education and training.
Assist in policy and procedure development within the department.
Requirements
Bachelor's Degree with 7+ years in regulatory affairs or relevant field.
Medical device experience is required.
Experience with 510(k) or PMA submissions for FDA.
Knowledge of U.S. and EU regulations for medical devices.
Excellent communication and presentation skills.
Ability to manage multiple projects with attention to detail.
Proficiency in MS Word, Excel, and PowerPoint.
Benefits
Competitive salary and flexible benefits package.
Health, Dental, and Vision insurance.
401(k) plan with employer match.
Paid time off and holidays.
Tuition assistance and reimbursement.
Employee Stock Purchase Plan.
Short-term disability and life insurance.
Employee Assistance Program.
Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$58k-85k yearly est. Auto-Apply 4d ago
Regulatory Lead, Operator
The Wing 3.9
Remote job
About Wing:
Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are inefficient, costly, and contribute to road accidents and air pollution. Wing's fleet of highly automated delivery drones can transport small packages directly from businesses to homes on-demand, in minutes. We design, build, and operate our aircraft, and offer drone delivery services on two continents. Our technology is designed to be easy to integrate into existing delivery and logistics networks, offering a scalable drone delivery solution for a broad range of businesses. Wing is a part of Google's parent company, Alphabet, and our mission is to create the preferred means of delivery for the planet. If you're ready to do the greatest work of your life, come join us.
About the Role:
Wing is looking for an Regulatory Lead, Operator to join our Global Aviation Regulatory Team. This role is based remotely in the US and reports to the Global Aviation Regulatory Lead. You will be responsible for leading Wing's regulatory strategy for the development, approval, and sustainment of our operational authorizations worldwide. Additionally, the Aviation Regulatory Lead will play a key role in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities. The ideal candidate will bring a deep understanding of today's uncrewed aircraft systems operational regulations in the US and around the globe along with emergent rulemaking that may impact Wing's future operations. The successful candidate will utilize this knowledge and expertise to provide leadership for Wing's future operator regulatory compliance strategy. This position will work closely with the flight operations teams to ensure compliance with applicable regulations but also develop innovative approaches to support our drone delivery business case. This role requires excellent written and verbal communication skills and the ability to collaborate with cross-functional teams. Ideal candidates have a passion for aviation and technology and are eager to learn and search for solutions in a dynamic and constantly evolving environment.
What You'll Do:
Lead the development, submission, and defense of comprehensive Operating Safety Cases to secure operational authorizations (e.g., Air Operator Certificate for the US, Specific Category approvals in the UK and EU, etc.) and airspace access (e.g., BVLOS/airspace waivers, special flight authorizations) from aviation regulators worldwide.
Collaborate closely with other key engineering and operational stakeholders in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities.
Interface routinely with various stakeholders across the company to ensure that all stakeholders understand the evolving regulatory environment and its impact on Wing's activities.
Collaborate with other members of the aviation regulatory team supporting their respective functions for Wing's operations around the world.
Actively participate in the development of industry consensus standards related to the functional domain of expertise.
Proactively stay up-to-date with evolving regulations related to the functional domain of expertise, while developing and proposing alternative approaches to enable the company's innovative systems to keep on pioneering the drone delivery market.
What You'll Need:
Bachelor's degree in aviation, engineering,or a related field, or relevant technical experience. A Master's degree in aviation, engineering, or a related field is a plus.
Minimum 12+ years of experience in aviation regulatory affairs, or a similar role, with a strong focus on air carrier operations (e.g. Part 135) or advanced UAS/drone operations.
Proven track record of successfully securing and managing complex operational and airspace authorizations from major global aviation regulators (e.g., FAA Part 135, EASA/CASA/UK SORA, etc.).
Excellent communication and collaboration skills to work effectively with cross-functional teams, with the ability to articulate complex technical and regulatory concepts clearly to regulators and technical teams.
Startup mentality, resourceful and resilient with the ability to get things done in dynamic circumstances.
Ability to travel nationally and internationally (as needed).
The US base salary range for this full-time position is the salary range below + bonus + equity + benefits. Wing's salary ranges are determined by role, level, and location. Your recruiter can share more about the specific salary range for your location during the hiring process.
Salary Range$134,000-$259,000 USD
Wing is an equal opportunity employer and it is Wing's policy to comply with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity. Employment at Wing is based solely on a person's merit and qualifications directly related to professional competence. Wing does not discriminate against any employee or applicant because of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), or any other basis protected by law.
If you have a need that requires accommodation during the interview process due to a disability or special need, please let us know by completing our Candidate Accommodations Request Form.
$37k-70k yearly est. Auto-Apply 4d ago
Financial and Regulatory Analyst
Centracare Health System 4.6
Remote job
Find your purpose as a Financial and Regulatory Analyst at CentraCare. The Financial and Regulatory Policy Analyst serves as a cross-functional expert supporting financial analysis, payer policy review, and regulatory compliance. This role is responsible for evaluating the financial and operational impact of payer policies, government reimbursement regulations, and healthcare legislation. The analyst partners with managed care, revenue cycle, government reimbursement, compliance, and clinical operations teams to ensure alignment with payer requirements, optimize reimbursement, and mitigate regulatory risk.
Schedule:
* Full-time 72 hours every 2 weeks
* Hours between Monday - Friday 8:00a-5:00p CST
* Fully remote
Pay and Benefits:
* Starting pay begins at $63,747.33 per year and increases with experience.
* Salary range: $63,747.33-$95,642.90 per year
* Salary range is based on a 1.0 FTE, reduced FTE will result in a prorated offer rate
* We offer a generous benefits package that includes medical, dental, flexible spending accounts, PTO, 401(k) retirement plan & match, LTD and STD, tuition reimbursement, discounts at local and national businesses and so much more!
Qualifications:
* Bachelor's degree in Finance, Health Administration, Public Health, Economics, or related field or 5+ years of experience in financial analysis, strong report-building skills, payer relations, or regulatory affairs in a healthcare environment.
* Understanding of Medicare and Medicaid payment systems, managed care contracts, and payer policies required.
* Proficiency in Excel and financial modeling; ability to interpret large datasets required.
* Familiarity with EHR and revenue systems (e.g., Epic, Lawson, Strata, or similar) preferred.
* Experience with payer audits, prior authorization processes, and coverage policy review preferred.
* Strong analytical, report creation, and critical thinking skills.
* Clear written and verbal communication.
* Regulatory and policy acumen.
* Detail orientation with the ability to synthesize complex information.
* Collaboration and stakeholder engagement
Core Functions:
* Payer Policy & Regulatory Intelligence
* Monitor and interpret payer policy updates, government reimbursement rules (e.g., Medicare, Medicaid, commercial plans), and legislation impacting financial performance.
* Analyze changes in payer coverage determinations, billing guidelines, and authorization policies to assess impact on access, documentation, and reimbursement.
* Collaborate with internal stakeholders to implement payer policy changes and ensure compliance across the revenue cycle and clinical departments.
* Identify opportunities for revenue enhancement and cost reduction through proactive management of payer policies.
* Financial Analysis & Forecasting
* Build and maintain financial models to forecast the revenue impact of regulatory or payer policy changes.
* Analyze variances in net revenue, denials, and reimbursement trends related to policy shifts and provide regular reports to the HealthCare Affordability Committee.
* Support budget planning and value-based contract modeling by incorporating regulatory and policy data.
* Develop metrics to track policy compliance, identify gaps, and propose solutions to improve processes and outcomes.
* Document and communicate findings, recommendations, and action plans to the HealthCare Affordability Committee.
* Regulatory Compliance & Reporting
* Track regulatory requirements from CMS, state Medicaid agencies, and commercial payers.
* Collaborate with compliance teams and revenue integrity teams to implement and maintain internal controls and audits to minimize risk.
* Collaborate with payer relations to address any payer-policy-related issues.
* Monitor adherence to payer policies across the organization.
* Partner with clinical and operational teams to ensure policy changes are implemented efficiently and effectively.
* Collaborate with the legal department to review and interpret contracts, agreements, and regulations.
* Communicate effectively with payers to clarify policy details and resolve disputes.
* Work closely with the revenue cycle management team to optimize claims processing and reimbursement.
* Cross-Functional Collaboration
* Act as a liaison between Finance, Compliance, Managed Care, Revenue Cycle, and Clinical Operations teams.
* Analyze clinical vendor reimbursement assumptions.
* Deliver policy summaries and financial impact briefs to operational leaders, with clear recommendations.
* Support stakeholders on new or updated payer policies and regulatory requirements.
CentraCare has made a commitment to diversity in its workforce and all individuals, including, but not limited to, individuals with disabilities, are encouraged to apply. CentraCare is an EEO/AA employer.
$63.7k-95.6k yearly Auto-Apply 27d ago
Specialist, Regulatory Operations
Care Access 4.3
Remote job
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference Care Access is seeking a skilled and experienced Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department. The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required. You will have a good understanding of U.S. regulatory requirements and experience supporting regulatory activities for clinical research sites. How You'll Make An Impact
Study-specific regulatory operations:
Act as main regulatory operations contact for assigned studies
Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, -OHRP and global regulatory standards.
Coordinates preparation and review of key site essential records.
Assist in preparing for sponsor monitoring visits and follow up requirements, ensuring compliance and --readiness for assigned studies.
Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
Track essential records and timelines
Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
Actively work towards KPIs to help ensure departmental success
Supports creation and maintenance of study Delegation of Authority (DOA) logs
Support regulatory activities throughout the duration of the study life cycle; collaborating with clinical operations teams to ensure regulatory compliance
Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study.
Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials.
Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback.
Liaise and follow up directly with Sponsor.
Ensures accurate compilation, management and tracking of submissions.
Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements.
Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes.
Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents for regulatory inspections and sponsor audits.
Milestones: Tracks and updates the study team accordingly
Other Responsibilities
Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.
Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Ability to communicate and work effectively with a diverse team of professionals
Communication Skills: Good verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
Good computer skills with demonstrated abilities using clinical trials database, MS word and excel
Experience in electronics Investigator Site Files systems like (Florence, CRIO)
Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
High level of self-motivation and energy
Ability to work independently in a fast-paced environment with supervision
Must have a client service mentality
Demonstrated success in managing IRB submissions
Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges
Ability to handle multiple tasks in a fast-paced and constantly changing environment.
Certifications/Licenses, Education, and Experience:
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience
Minimum of 2 years of experience in operational regulatory affairs within theresearch site (preferable), or -CRO/pharmaceutical industry.
Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
Good knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.
How We Work Together
Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$60k-88k yearly est. Auto-Apply 2d ago
Regulatory Specialist (Hybrid Opportunity)
Stanford University 4.5
Remote job
**School of Medicine, Stanford, California, United States** Research Post Date Nov 19, 2025 Requisition # 107768 The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Divisionis seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. The position will anticipate and generate reports and prepare documents for submission as required by the IRB, FDA, OSP and APB requirements, including annual reports, and IND safety reports. The position will author and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in support of BMT-CT clinical research and coordinate with the Stanford Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will gather, evaluate, organize and manage information from a variety of sources to draft/finalize biomedical research protocols during the development phase, including draft content and formatting to meet requirements of Stanford, Institutional Review Board (IRB), United States Food and Drug Administration (FDA), Office of Science Policy (OSP) and APB (Biosafety Committee).
The BMT-CT program at Stanford performs autologous and allogeneic transplantations for over 400 patients each year. The program has been very successful with a history of limited morbidity rates and acute mortality that is well below most published reports. In addition to a successful clinical practice, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide.
This is a hybrid eligible position.
**Duties include:**
+ Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.
+ Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development.
+ Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
+ Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.
+ Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.
+ Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
+ May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.
+ May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.
+ May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.
**DESIRED QUALIFICATIONS:**
+ Experience with Protocol/IND writing.
+ Experience with BMT-CT disease focus.
**EDUCATION & EXPERIENCE (REQUIRED):**
+ Bachelor's degree and five years of related experience or a combination of education and relevant experience.
**KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):**
+ Excellent communication and organizational skills and superb attention to detail.
+ Experience with MS Office products and database applications required.
+ Excellent inter-personal skills and customer service focus is required.
+ Experience in clinical research management and oversight, including project management in a dynamic research setting.
+ Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
+ Experience in developing and implementing training/education.
+ Demonstrated ability to manage multiple projects and staff under varying time constraints.
+ Strong writing skills.
**PHYSICAL REQUIREMENTS*:**
+ Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
+ Occasionally sit, use a telephone or write by hand.
+ Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
**WORKING CONDITIONS:**
+ May require occasional local and overnight travel.
**WORKING STANDARDS:**
+ Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
+ Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
+ Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,********************************
**The expected pay range for this position is $123,470 to $143,544 per annum.**
**Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.**
**At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (** ******************************************************** **) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.**
**Why Stanford is for You**
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture andunique perksempower you with:
+ **Freedom to grow.** We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
+ **A caring culture.** We provide superb retirement plans, generous time-off, and family care resources.
+ **A healthier you.** Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
+ **Discovery and fun.** Stroll through historic sculptures, trails, and museums.
+ **Enviable resources.** Enjoy free commuter programs, ridesharing incentives, discounts and more.
_Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a_ _contact form_ _._
_Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law._
_The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned._
Additional Information
+ **Schedule: Full-time**
+ **Job Code: 4942**
+ **Employee Status: Regular**
+ **Grade: I**
+ **Requisition ID: 107768**
+ **Work Arrangement : Hybrid Eligible**
$123.5k-143.5k yearly 59d ago
Entry Level Chemical Regulatory Analyst (Remote)
Environmental Science 3.7
Remote job
Shift:
Monday through Friday, 8:00AM - 5:00PM
Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.
Make an impact. Build a career.
At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That's why we need you - your curiosity, your talents, and your drive - to help us advance this important work, and your career.
Find your place at Pace Join us as a Regulatory Analyst, where you'll put your love of science to work in the Scientific Insourcing Services department. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace .
This candidate will work with vendors to seek out chemical information in an entry-level regulatory services position. This is a great entry-level position to learn global chemical regulations for a wide range of materials. This is a non-laboratory position.
Compensation: $20.00 per hour
NOTE: Remote position
What you'll do:
Input information from vendor safety data sheets into a hazard communication database
Review global chemical regulations and determine their application for various products
Search for SDS sheets of raw materials
Fill in missing or incorrect information in the SDS sheets
Contact vendors as needed
What you'll bring:
Bachelor's degree in Biology, Chemistry, Biochemistry, or related science.
Experience with Microsoft Office
Ability to learn new computer software
Customer service experience preferred
Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.
Benefits
When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$20 hourly Auto-Apply 2d ago
Regulatory Analyst II
GCI Communication Corp 4.7
Remote job
GCI's Regulatory Analyst II will create, implement, and ensure GCI's compliance with regulations. Prepare monthly carrier access billings and pool/settlement reporting; monitor and maintain access minute reporting functions; prepare, maintain, and interface with regulatory agencies filings for state and interstate tariffs, rate postings, Federal Universal Service Fund, and the Alaska Universal Service Fund; assist in preparation of cost studies and network use analyses; perform other regulatory/financial work. Keep appraising any regulation changes on both the state and federal side and offer interpretation. Prepare company tariffs and rate postings under both federal and state regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES AT ALL LEVELS:
Regulatory Filing Preparation and Analysis:
Read and interpret FCC, RCA, and other regulatory entity rules, regulations, and procedures. Analyze and offer recommendations in response to any upcoming regulatory issues. Seek out, notify, and coordinate with other personnel within the organization to ensure process creation and ongoing compliance. Prepare reports and filings with regulatory bodies to ensure accurate receipt of Universal Service fund support and pooled earnings. Create processes, interpret changes, and maintain accurate documentation regarding each filing and the regulation or rule driving it.
Tariff/Posting Preparation:
Audit, preparation and filing of access tariffs as well as tariff interpretations and quotes; maintenance of local and long-distance rate postings, terms, and conditions. Coordination with other departments to maintain compliance. Streamline and automated processes where necessary.
Access Minute Management:
Act as first point of contact for Local Exchange Carrier (LEC) CABs preparers. Manage trunk tables to ensure accurate access minutes are being captured and review monthly files sent to LECs. Work closely with IT Analysis to ensure data integrity. Calculate quarterly billing factors and maintain records sufficient for audit.
Carrier Access Billing (CABs):
Prepare monthly CABS billing and related analysis. Use reports from the CABs system as needed to analyze trends and monitor the integrity of the CABs bill. Follow-up and resolve any trend analysis anomalies. Reconcile and balance billing reports used for Connect America Fund (CAF) filings. File Network Access Fee (NAF) revenues, Intrastate minutes of use, and switched circuits in the Alaska Exchange Carriers Association (AECA) portal.
COMPETENCIES:
+ ACCOUNTABILITY- Takes ownership for actions, decisions, and results; openly accepts feedback and demonstrates a willingness to improve.
+ BASIC PRINCIPLES - Interacts with people in a way that builds mutual trust, confidence, and respect; adheres to GCI's Code of Conduct for Employees - the Basic Principles.
+ COLLABORATION - Works effectively with others to accomplish common goals and objectives; maintains positive relationships even under difficult circumstances.
+ COMMUNICATION- Conveys thoughts and expresses ideas appropriately and professionally.
+ Ability to accurately communicate information virtually (i.e., Teams), over the phone, and in-person in a clear and concise manner to a range of audiences.
+ Ability to accurately read, write, and respond to business correspondence such as emails, chat messages, policies, procedures, reports.
+ Ability to multitask in a faced paced environment with successful results.
+ COMPLIANCE - Follows internal controls; protects confidential information; abides by GCI's Code of Business Conduct & Ethics.
+ CUSTOMER FOCUS - Demonstrates commitment to service excellence; gives high priority to customer satisfaction.
+ RELIABILITY - Consistently follows through on assigned tasks as expected; demonstrates timely attendance at meetings, training, and other work obligations.
+ RESULTS - Uses a combination of job knowledge, initiative, sound decision making, innovation, adaptability, and problem solving.
+ SAFETY & SECURITY - Supports a safe work environment by following all workplace safety rules and guidelines; complies with applicable Security policies and procedures.
+ TECHNICAL PROFICIENCY - Proficient computer skills and MS Office knowledge (e.g., Outlook, Teams, Word, Excel) to complete job duties effectively, such as using the company intranet and to accurately retrieve and input information into database or equivalents.
Additional Job Requirements:
Intermediate level analyst position. Must have a comprehensive understanding of telecommunications, and ability to follow documented procedures with no supervision. Works under moderate supervision and supports team. Requires ability to execute complex procedures. High degree of self-initiative and be able to prioritize and handle multiple tasks with independent decision-making. Individual must lead team members and effectively communicate directions.
Minimum Qualifications:
Required: *A combination of relevant work experience and/or education sufficient to perform the duties of the job may substitute to meet the total years required on a year-for-year basis
+ High School diploma or equivalent.
+ Bachelor's Degree in business administration, Finance, Economics, or related field.*
+ Minimum six (6) years of increasing responsibility in regulatory, compliance or related regulated industry experience. *
Preferred:
+ Four (4) years of experience working in the telecommunications industry for mid- to large-size private business.
+ Other relevant telecom industry or job specific certifications.
DRIVING REQUIREMENTS:
+ This position may require access to reliable transportation for occasional travel between retail store locations, offices, worksites, or other locations as needed.
PHYSICAL REQUIREMENTS and WORKING CONDITIONS:
+ Work is primarily sedentary, requiring daily routine computer usage.
+ Ability to work shifts as assigned, work in standard office/home office setting, and operate standard office equipment.
+ Ability to accurately communicate information and ideas to others effectively.
+ Physical agility and effort sufficiently to perform job duties safely and effectively.
+ Ability to make valid judgments and decisions.
+ Available to work additional time on weekends, holidays, before or after normal work hours when necessary.
+ Must work well in a team environment and be able to work with a diverse group of people and customers.
+ Virtual workers must comply with remote work policies and agreements.
The company and its subsidiaries operate in a 24/7 environment providing critical services to Alaskans and may need to respond to public health and safety matters or other business emergencies. Due to business needs employees may be contacted outside of the core business hours to respond to the immediate emergency. As such, you will be requested to provide emergency after-hour contact numbers, to include your home and cell phone numbers if you have those services.
Culture, Engagement, and Connection: At GCI, we foster an environment where the unique perspectives of our employees, customers, and fellow Alaskans are celebrated. We add value to our community by nurturing and empowering each member of our workforce, ensuring equal opportunities for every Trailblazer.
EEO: GCI is an equal opportunity employer. Qualified applicants are considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, mental or physical disability, veteran status, or any other status or classification protected under applicable state or federal law.
DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
All employees of GCI work in support of the GCI Mission Statement and Declaration of Principles which are located on the GCI Career page and Employee portal.
$53k-65k yearly est. 29d ago
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