- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Titusville, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey or Pennsylvania. At Johnson & ... where no other precedents exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional … more
- Merck (Upper Gwynedd, PA)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory...submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product… more
- Merck (North Wales, PA)
- …of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr.… more
- Merck (North Wales, PA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary,...targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product… more
- Lilly (Philadelphia, PA)
- …people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory activities for ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson is currently seeking a Director , Regulatory Medical Writing. The primary location for this position is the United States. Secondary locations ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Merck (Trenton, NJ)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... **Job Description** The Executive Director , Device Quality & Regulatory will... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible ... are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans....for the execution (in conjunction with the TMED Operations Lead ) and reporting thereof. The Director will… more
- Merck (North Wales, PA)
- …Global Oncology Marketing** for Lung cancer for our Company's oncology business. The Global Marketing Director will lead strategies and marketing efforts ... in Rahway, NJ and will report to the Executive Director , Global Marketing for NSCLC. The position...NSCLC working in conjunction with Precision Marketing team + Lead in liaising with Outcomes Research, Global … more
- Merck (West Point, PA)
- …Continuity Planning (BCP), including identification & prioritization of mitigation strategies + Lead Global Filing and Launch (GFLS) strategy development to gain ... Leader will be responsible for supply chain design, global filing and launch strategy, long-range demand vs capacity...continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply Chain… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in...Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them + Perform tasks of… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , TA (Therapeutic Area) Analysis Standards Leader is accountable ... TA, aligning cross-functionally and driving end to end standards. Associate Director , TA Analysis Standards Leader , independently leads improvement initiatives… more
- Wolters Kluwer (Princeton, NJ)
- …for products and applications. We have an amazing opportunity for a **Associate Director of Global Information Security Identity & Access Management** available ... within our Global Business Services division! The Associate Director ...office. As the IT Security Delivery Manager, you will lead a team of information security professionals and be… more
- Abbott (Princeton, NJ)
- …changes in medical science and technology. Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products ... Abbott is a global healthcare leader that helps people...Lead the development and ongoing maintenance of the global value dossier, detailing clinical, economic and patient-centered evidence… more
- Bristol Myers Squibb (Princeton, NJ)
- … , this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program into...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access C&E… more