- Insmed Incorporated (Bridgewater, NJ)
- …close collaboration with Regulatory project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for creating (and/or updating) ... content, guiding internal review, and facilitating the approval process for labeling content for Insmed marketed and to-be-marketed products, including but not… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... as: target product profile development, global regulatory filing strategy, labeling , launch readiness reviews, organized customer interactions, market research,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... issues related to development compounds or marketed products including labeling discussions/updates; Provides medical insight to draft responses to regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL-… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs.… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Director Global Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden);… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... development and implementation of labeling content and strategy of multiple assigned products in...you will contribute:** With guidance from leadership: Management of Labeling Cross-Functional Teams + Independently leads Labeling … more
- Takeda Pharmaceuticals (Columbus, OH)
- …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 ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… 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 specific ... the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with US regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling … more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... development and implementation of labeling content and strategy of assigned product(s) in various...for providing support to the development and implementation of labeling content and strategy of high complexity product(s). **How… more
- Merck (Rahway, NJ)
- … Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:** + Developing, maintaining, ... **Job Description** The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling … more
- Bausch Health (Bridgewater, NJ)
- …in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are ... mission of improving people's lives with our health care products. The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates… more
- Teva Pharmaceuticals (West Chester, PA)
- …process development, device development, analytical methods, formulation development, manufacturing, and labeling . The Sr Director , Regulatory Affairs CMC is ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun...to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …promotional information, materials, and activities to ensure consistency with product labeling and with all applicable regulations. TheSenior Director , ... real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and execution… more
- Bausch Health (Bridgewater, NJ)
- …improving people's lives with our health care products. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors ... prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides… more
