- 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
- 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
- CSL Behring (King Of Prussia, PA)
- …to you as a CSL employee. **About CSL Behring** CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with ... The Sr. Director , Head of Global Medical Information...preferred *Experience building and leading matrixed teams in a global organization *Influential leader who builds relationships… more
- Wolters Kluwer (Philadelphia, PA)
- …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
- CSL Behring (King Of Prussia, PA)
- …of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market ... often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead ? This...CSL employee. **About CSL Behring** CSL Behring is a global leader in developing and delivering high-quality… more
- Merck (North Wales, PA)
- …competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized ... **Job Description** We are currently recruiting for a ** Global Marketing Director ** for metastatic lung cancers. Our Marketing team is passionate about bringing… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson is recruiting a Director of Radioligand Therapies, Global MSAT (Advanced Therapies) to be located in Spring House, PA, Malvern, PA, Raritan, ... Working closely with Development and Supply Chain teams, this Director of Radioligand Therapy will help establish a manufacturing...chain. This role partners closely with R&D, Quality, and Regulatory to ensure processes meet the needs of today… more
- Wolters Kluwer (Philadelphia, PA)
- …Wolters Kluwer is looking for an accomplished and experienced **IT Security Associate Director - Security Governance Lead ** to join our Strategic Security ... Security. This critical role will oversee and improve our global IT & Cybersecurity Governance, Risk, Regulatory ...IT risk and control capabilities. The IT Security Associate Director will report to the head of Strategic Security… more