- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The 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 will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Early Development), may be ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... and execution of the post-approval regulatory strategy , post-marketing commitments,post-marketing development and maintenance,...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …exciting opportunity within our US Medical Affairs leadership team for a Senior Director , Medical Affairs Strategy within Liver Disease. **This role will ... Director USMA Liver Disease, the Senior (Sr.) Director Medical Affairs Strategy role...meetings. + Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...Amgen's GRAAS organization + To independently develop a comprehensive regulatory strategy for one or more high… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well… more
- New York State Energy Research and Development Aut (Albany, NY)
- …residents to benefit equitably from energy efficiency and renewable energy. Job Overview The Director of Regulatory Affairs will report to the Vice President ... of Government and Regulatory Affairs and be responsible for building... team within NYSERDA. Working with the VP, the Director will lead cross-cutting and inter-agency policy advancement activities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …an exciting opportunity within our US Medical Affairs Liver team for a Director , Medical Affairs Strategy for Primary Biliary Cholangitis. **This role is ... based in Foster City, CA.** ** Director , US Medical Affairs (USMA)Liver - PBC**...care. + Ability to think strategically and translate that strategy into an actionable work plan. + Excellent written,… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... RA leadership team representative. + Responsible for the global regulatory strategy for UCC products + Leads...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- ADM (Kennesaw, GA)
- … Affairs H&W NA **Department/Function:** Health, Safety & Environment **Job Description:** ** Director Regulatory & Scientific Affairs , Health & Wellness - ... This is an Exempt level position. **Position Summary:** The Director Regulatory & Scientific Affairs ,...support for the definition and execution of the commercial strategy in North America. This role works in conjunction… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia... considerations into the APAC product entry and exit strategy . + Recruit, develop and manage regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional...need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Soft Tissue Fillers MPS ... to support renewals. Directs and supports development of the regulatory strategy related to MPS activities for... Regulatory Affairs colleagues. + Provides regulatory policy, intelligence interpretation and strategy (eg,… more