- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to cross-functional ... and/or in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams… more
- BeiGene (Emeryville, CA)
- …and EU (EMA). + Experience with global regulatory health authorities, including successful submissions and interactions with agencies such as FDA , EMA, and PMDA. ... The Executive Director of Regulatory Affairs, Companion Diagnostics (CDx) will...products, ensuring compliance with regulatory agencies such as the FDA , EMA, and other health authorities. This role will… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct ... bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define,...as original NDA/BLAs. + Direct point of contact with FDA , leads and manages FDA meetings. Manages… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , North American Regional Lead (NARL)/Global Regulatory Leader (GRL), to support the initiatives ... reach their potential. At Johnson & Johnson, we all belong. The Director , North American Regional Leader/Global Regulatory Leader, is responsible for North American… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global ... company. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct ... to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide strategic and… more
- J&J Family of Companies (Raritan, NJ)
- …of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director , North America Regulatory Leader in Raritan, NJ. Remote work options may be ... science, to lead the team in discussions with US FDA and Health Canada Agency to find the best...the execution of regulatory plan for select health authority submissions and projects through close collaboration with multiple functional… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible ... objectives. Serve as the liaison and manages correspondence with FDA 's promotional review divisions Office of Promotion and Advertising Review(OPDP)/Advertising… more
- Novo Nordisk (Lexington, MA)
- …level strategic input into development plans, study designs, and regulatory submissions . Relationships The Associate Director , Medical Writing (ADMW) reports ... ready to make a difference? The Position The Associate Director is an expert in medical writing and performs...documents and plans to support clinical operations and regulatory submissions across a range of development programs and therapeutic… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; ... can reach their potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader, is responsible for global regulatory strategies for select… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Director of Global Rgulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in the San Fran ... career, trust **The Experts at Hiring Experts.** **Position Overview:** The Director , Global Regulatory Affairs is responsible for contributing to the development… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct ... strategies in collaboration with their regional counterparts. **Accountabilities:** + The Director will be responsible for complex or highly complex or multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …orchestrate meetings and teleconferences with FDA + Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough therapy ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Inovio Pharmaceuticals (Plymouth Meeting, PA)
- …knowledge of the relevant current requirements for medical device and combination product submissions to FDA , prior interaction or exposure with other key ... tools. For more information, visit www.inovio.com . Job summary The Senior Director , Regulatory Affairs, Combination Products will have a broad span of… more
- Walgreens (Deerfield, IL)
- …**Job Summary** Walgreens RWE Clinical Trials is seeking an experienced Medical Director role to provide medical oversight and leadership serving as Principal ... new clinical trials for the business. Major duties of the Medical Director are outlined below: **Job Responsibilities:** **Medical Business Leadership** + Provides… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough ... US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions , shortening...ensure that FDA receives timely and quality submissions , shortening the review process and leading to successful… more
- Takeda Pharmaceuticals (Boston, MA)
- …timelines as per R&D and business objectives. + Accountable for all US FDA submissions and approvals for assigned programs. Works cross-functionally with RA ... submissions + Strong knowledge of global regulatory requirements and prior FDA interactions/ submissions experience + Ability to use precedent and previous… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …in discussions with external and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic company guidance on ... FDA and global regulatory requirements (affairs and CMC) for...Regulatory CMC function in preparing high-quality CMC related regulatory submissions and supports the Regulatory CMC leads in interactions… more
- AbbVie (Waltham, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC), you ... creating CMC regulatory strategies that facilitate first-pass approvals of regulatory submissions . This involves developing and managing content strategies for … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …projects/programs in a regulated industry. And Minimum of 5 years working with FDA on regulatory submissions . Must have people management experience Experience ... Director , REMS Operations Date: Feb 7, 2025 Location:...program meetings. Interfaces with Regulatory department for REMS document submissions . + Identify opportunities to enhance REMS processes and… more