- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Merck & Co. (Rahway, NJ)
- …Leadership Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... MAA) and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs ( RA ) Business Operations believe talented ... be purposeful and impactful! Reporting into the Head of RA Business Operations, RA Performance Excellence, you...cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg,… more
- Bristol Myers Squibb (Princeton, NJ)
- …Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC, the Associate...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Merck (Rahway, NJ)
- …Leadership Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... limited CMC post-approval changes. + Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the… more
- Bristol Myers Squibb (Princeton, NJ)
- … Director Regulatory Policy brings an expertise in regulatory affairs and related policy. The Associate Director , Regulatory Policy is responsible ... and actionable outcomes. The incumbent acts as a critical link between global , regional, and local regulatory environments, ensuring the business stays… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Sanofi Group (Morristown, NJ)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... **Job Title:** GRA Device Lead (Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham,...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Sanofi Group (Morristown, NJ)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... **Job Title:** GRA Device Lead (Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Sanofi Group (Morristown, NJ)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...within Global Research and Development. Sanofi's global regulatory affairs (GRA) function… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
