Senior Manager, US Regulatory Affairs

4 days ago


New York, New York, United States Haleon Full time
About the Role

Haleon is seeking a highly skilled Senior Manager to lead our US Regulatory Affairs team for the Wellness portfolio. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies that ensure compliance with dietary supplement regulations.

As a Senior Manager, you will provide leadership to cross-functional teams, including product development, medical, legal, and marketing. You will also build strong relationships with internal and external stakeholders, including regulatory agencies and industry associations.

Key Responsibilities
  • Develop and implement regulatory strategies for new product launches and maintenance of current products in the market.
  • Manage compliance within defined portfolio/activity streams in line with Haleon expectations.
  • Support key processes and ways of working, including product labeling requirements, quality, and local regulations.
  • Support the development of strong claims/advertising and promotion within regulations, ensuring risks are appropriately addressed and communicated.
  • Provide development, coaching, and mentorship to the Wellness regulatory team.
  • Collaborate with stakeholders to ensure regulatory contributions achieve objectives in the strategy, achieve agreed standards, and maximize overall project delivery time and POS.
  • Proactively identify potential risks and manage the impact of regulatory changes within defined scope of responsibility on the business.
  • Maintain a high level of knowledge on the science of products and ingredients within the portfolio.
  • Review and approve artwork for dietary supplements.
  • Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.
External Engagement
  • Monitor regulatory trends that could impact the portfolio, identify, and report the impact of business.
  • Active participant externally in industry association activities, ensuring that Haleon's point of view is considered.
Business Expertise
  • Proven knowledge of the competitive and regulatory landscape for dietary supplements, and how to apply that knowledge when assessing new product opportunities, ingredients, and claims.
Problem Solving
  • This role will independently sit on project teams. The regulatory environment for dietary supplements is complex and dynamic. This role must be able to navigate ambiguous regulatory scenarios and provide balanced advice in a manner that can be acted on by commercial teams.
Nature and Area of Impact
  • This role is primarily internally facing. Because this role largely deals with regulatory compliance, impact can be broad within the US business. Strong organizational skills with out-of-the-box thinking are a must.


  • New York, New York, United States Randstad Life Sciences US Full time

    Randstad Life Sciences US is seeking a Senior Regulatory Affairs Consultant with 10-15 years of experience to join their dedicated Regulatory Affairs team. This role is pivotal in ensuring that the company's innovative products navigate the complex regulatory landscape efficiently and remain compliant with global regulatory requirements. The ideal candidate...


  • New York, New York, United States EUSA Pharma Full time

    Job SummaryThis is a senior-level position within the Regulatory Affairs department at Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati. The successful candidate will be responsible for managing RRD's Regulatory Affairs Lifecycle Management for assigned products across multiple therapeutic areas in the US and Canada.Key...


  • New York, New York, United States Barrington James Full time

    Senior Regulatory Associate - Hybrid, NJ (2-3 days a week)Barrington James is partnering with a global commercial pharmaceutical company that is passionate about bringing generic drugs to market across multiple formulations and dosage forms. They are seeking an Associate Manager or Manager to join their team in a hybrid role based in New Jersey (2-3 days a...


  • New York, New York, United States Stryker Full time

    Senior Staff Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division based in Weston, FL or Mahwah, NJ.About the RoleThis is a key position that will support Stryker's Joint Replacement Robotics and Digital medical device hardware and software new product development and...


  • New York, New York, United States MetroPlusHealth Full time

    Job Title: Senior Director of Regulatory AffairsAt MetroPlusHealth, we are committed to empowering New Yorkers by uniting communities through care. We believe that healthcare is a right, not a privilege. If you have compassion and a collaborative spirit, we invite you to join our team.About MetroPlusHealthMetroPlusHealth provides the highest quality...


  • New York, New York, United States MetroPlusHealth Full time

    Job Title: Senior Director of Regulatory AffairsAt MetroPlusHealth, we are committed to empowering New Yorkers by uniting communities through care. We believe that healthcare is a right, not a privilege. If you have compassion and a collaborative spirit, we invite you to join our team.About the RoleThe Senior Director of Regulatory Affairs will lead a team...


  • New York, New York, United States Oscar Health Full time

    About the RoleOscar Health is seeking a highly skilled Senior Regulatory Affairs Analyst to join our Corporate Counsel team. As a key member of our team, you will play a critical role in maintaining and operating the Independent Dispute Resolution process.Key Responsibilities:Be the subject matter expert on assigned state and federal policy for provider...


  • New York, New York, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs.Key Responsibilities:Develop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country...


  • New York, New York, United States SPCSHP Full time

    Job Title: Senior Specialist, Regulatory AffairsAbout the Role:We are seeking a highly skilled Senior Specialist, Regulatory Affairs to join our team at SPCSHP. As a key member of our Regulatory Affairs team, you will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising campaigns.Key...


  • New York, New York, United States Synchron LLC Full time

    About SynchronSynchron is a pioneering clinical-stage endovascular brain computer interface (BCI) company that has been revolutionizing the field since 2012. Our mission is to develop a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment.Job Title: Senior Regulatory Affairs SpecialistWe are seeking a highly...


  • New York, New York, United States Oscar Health Full time

    Job Title: Regulatory Affairs SpecialistOscar Health is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Legal & Government Affairs team.About the RoleThe Regulatory Affairs Specialist will play a critical role in ensuring that Oscar Health complies with all relevant state and federal regulations. This includes tracking and...


  • New York, New York, United States Willson International Limited Full time

    Job Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Willson International Limited. As a key member of our organization, you will be responsible for managing provisions of broker regulations set forth in 19 CFR 111 and various participating government agencies to ensure requirements are met or...


  • New York, New York, United States Oscar Health Full time

    About the RoleOscar Health is seeking a highly skilled Regulatory Affairs Manager to join our Corporate Counsel team. As a key member of our team, you will play a critical role in managing the Independent Dispute Resolution process and ensuring compliance with all applicable laws and regulations.Key ResponsibilitiesMentor and Train Colleagues: Provide...


  • New York, New York, United States New Millenium Consulting Full time

    Job SummaryWe are seeking a highly experienced Regulatory Affairs Project Manager to join our team at New Millenium Consulting. As a key member of our Regulatory Affairs team, you will be responsible for delivering complex projects within our Program portfolio.Key ResponsibilitiesProject Delivery: Responsible for the delivery of regulatory change management...


  • New York, New York, United States Oscar Health Full time

    Job Title: Regulatory ManagerOscar Health is seeking a highly skilled Regulatory Manager to join our Corporate Counsel team. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements and managing the Independent Dispute Resolution process.About the RoleThe Regulatory Manager will be responsible for...


  • New York, New York, United States Tandym Group Full time

    Director of Regulatory AffairsTandym Group is seeking an experienced healthcare professional to join their leadership team as Director of Regulatory Affairs.Key Responsibilities:Performance Metrics and Outcomes: Identify areas needing improvement and design continuous measurement of performance metrics and outcomes.Compliance and Training: Create and deliver...


  • New York, New York, United States Intellectt Inc Full time

    Job Description:At Intellectt Inc, we are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in managing regulatory processes for medical devices or pharmaceuticals.Key Responsibilities:Prepare, review, and submit regulatory documents to regulatory authorities to support product...


  • New York, New York, United States NYC Health Hospitals Full time

    Job Title: Director of Regulatory AffairsNYC Health + Hospitals/Jacobi is a 457-bed teaching hospital affiliated with the Albert Einstein College of Medicine. The facility has earned numerous Center of Excellence designations, accreditation, and recognition for its renowned Level 1 Trauma Center, Burn Center, Surgical Intensive Care Unit, regional Stroke...


  • New York, New York, United States GForce Life Sciences Full time

    Job SummaryGForce Life Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and expertise on CMC regulatory matters to ensure compliance with global regulatory requirements and guidance.Key ResponsibilitiesCMC Regulatory...


  • New York, New York, United States GForce Life Sciences Full time

    Job SummaryInternal Job Regulatory Affairs Associate II12 months + ContractOnsite - Clark, NJKey ResponsibilitiesReview formulas for compliance with local regulations, in particular for US and CanadaReviewing artwork for US and Canada ComplianceReviewing US and Canada Claims requirementsNotifying products in US and Canada as neededCanada Chemical regulatory...