- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a ... part of our Global Regulatory Affairs organization.In this role, you will work in close collaboration with the Global Regulatory Lead(s) on a compound in… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; ... Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in … more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Solutions and Industry Partnerships -Vaccines **Location:** Remote **About the Job** As the Associate Director , ... designed for specific partnership channels + Work closely with HS Solutions, Public Affairs , HIT Solutions, Brand Marketing, and Market Access to ensure content both… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Haleon (Warren, NJ)
- …supplements. In line with a risk-proportionate framework for product vigilance, the ** Associate Director , Consumer Safety Science** is accountable for developing ... experience of product safety related disciplines (eg, clinical development, medical affairs , regulatory ) preferred. + Professional qualification as healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- AbbVie (Branchburg, NJ)
- …Key Stakeholders: PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs , Discovery, Clinical Operations Additional Information Applicable ... or Development Safety Update Report) for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV… more
- Edwards Lifesciences (Trenton, NJ)
- …their span of influence/control The Sr Manager, Biostatistics Level is lateral to Associate Director , Biostatistics (" Associate Director Biostatistics") ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
