- Catalent Pharma Solutions (Somerset, NJ)
- ** Associate Director , Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... safety of every patient, consumer and Catalent employee. The primary duty of the ** Associate Director , Regulatory Affairs ** is to support regulatory … more
- Novo Nordisk (Princeton, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will ... mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand 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
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned,… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- IFF (Hazlet, NJ)
- Associate Manager, Regulatory Affairs ...and customers. This role will be reporting to the Director of Regulatory Affairs , Americas. ... Hazlet, NJ, US, 07730 Company: IFF Family of Companies Job Description Associate Manager, Regulatory Affairs , NOAM (Hybrid) It's an exciting time to be… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities. Essential ... Functions: + Compilation of regulatory submissions including INDs, NDAs, amendments and supplements and manage submission timelines. + Mantain regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, you ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project...through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global … more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of… more
- Novo Nordisk (Princeton, NJ)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of...plans, study designs, and regulatory submissions. Relationships The Associate Director… more
- Amicus Therapeutics (Princeton, NJ)
- …with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is ... Associate Director , External Quality Lead (Small...Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced… more
- Sumitomo Pharma (Trenton, NJ)
- ** Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical ... seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible for the ... will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Project Scientist - 2406187180W **Description** Johnson & Johnson is currently seeking an Associate Director , Clinical ... Project Scientist to join the Oncology Global Medical Affairs group in Raritan, New Jersey. Remote based locations within the USA may be considered on a case by case… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Bristol Myers Squibb (Princeton, NJ)
- …to the Director , Worldwide Immunology & Neuroscience Communications, Corporate Affairs . The Associate Director , Worldwide Immunology Communications, ... policy and reputational goals. + Lead communication planning for regulatory submissions and product approvals; partner closely with Development Communications… more