- 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 ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a ... and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the regulatory… more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with… 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)
- …+ 4 or More Years of relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg integrated drug/diagnostic … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… 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)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Rare Blood Disorder and Neurology portfolio. As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products… more
- Bausch + Lomb (Bridgewater, NJ)
- … Associate degree, Bachelor degree preferred or equivalent + 0-1 year of Regulatory Affairs experience or relevant experience in a regulated environment + ... approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… more
- Sanofi Group (Bridgewater, NJ)
- …Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical ... **Job title: Device Regulatory Lead ( Associate Director)** + Location:...of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and… more
- Bristol Myers Squibb (Madison, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Working in coordination with key stakeholders in Generic R&D, Operations, Legal Affairs , Regulatory Affairs , Quality Management, Supply Chain, Global ... Associate Director, New Product Strategy - Parsippany, NJ...tight coordination with sales, marketing, supply chain, manufacturing, distribution, regulatory , quality and legal affairs . + Manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical ... experience in scientific/ regulatory fields required - Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc. is an equal… more
- Novo Nordisk (Princeton, NJ)
- …project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of the written ... deliverables that support the clinical development and regulatory requirements of a clinical program. The ... regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... areas centered around rare diseases and immune disorders. **Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... for cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. Responsibilities + Editorial Review of Materials Review and… more
- Amicus Therapeutics (Princeton, NJ)
- …External Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced activities with ... operations for small molecule products. Working in partnership with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is… more
- Ascendis Pharma (Princeton, NJ)
- …and develop their skills. Ascendis Pharma is looking to hire an experienced Associate Director, Market Access, Payor and Channel Marketing to join our team. ... such as Pricing, Contracting & Distribution (PCD), Brand Marketing, Medical Affairs , Finance, Legal, other Market Access colleagues, external customers and agency… more