- 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
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability ... to apply complex scientific and expert regulatory advice and risk assessment for the development of...risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,… 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
- Bausch Health (Bridgewater, NJ)
- …mission of improving people's lives with our health care products. he Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… 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
- Merck (Rahway, NJ)
- …a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within ... cross functional teams across multiple geographies and functions. + Exposure to Medical Affairs function within a reputed Pharma would be a plus + Strong strategic… 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
- 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
- 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
- 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
- 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
- Sanofi Group (Trenton, NJ)
- The **Medical Science Liaison (MSL) Associate Director ** will oversee the effective and efficient functioning of individual MSLs in the region. Ideal candidate ... **Territory** : Western Region (West of Chicago) The **MSL Associate Director ** main objectives are to; +...material such as slide decks, in collaboration with Medical Affairs Directors. + Train or advise internal stakeholders. +… 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
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Established Brands Associate Director is responsible for strategy and execution of ... to both clinical trial and post-marketing safety. + Familiarity with regulatory guidelines. + Considerable Multi-Brand Medical Affairs and… more
- Bristol Myers Squibb (Trenton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Clinical Nurse Consultant** _The Clinical Nurse Consultant ... (CNC) Associate Director is the leader of a...in other regional/field-based positions from the commercial and medical affairs organizations + Promote open dialogue with cross functional… more