- Astellas Pharma (Northbrook, IL)
- …of commercial products within a within a region. + Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early ... issues. + Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products.… more
- Medtronic (Fridley, MN)
- …engineer the extraordinary. Location is open to US-based Medtronic facilities. The Medtronic Global Regulatory Affairs team is seeking a highly motivated and ... individual to lead our Regulatory Affairs Education program within the Global Regulatory Affairs Organization. In this role, you will shape the future of … more
- Sumitomo Pharma (Nashville, TN)
- …groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... address the interests of the Company + Highly developed understanding of global regulatory dynamics + Unquestionable ethics, professional integrity, and personal… more
- Sumitomo Pharma (Tallahassee, FL)
- …position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the… more
- J&J Family of Companies (Raritan, NJ)
- …leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of ... are aligned with compound/program objectives and commitments. Work closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- … regulatory pathways. Define US strategic considerations in the generation of a Global Regulatory Strategy Document. + In cooperation with US/ Global ... expertise on projects in the assigned therapeutic area from the global regulatory , legislative, scientific, medical, pharmaceutical, pharmacovigilance, market… more
- Takeda Pharmaceuticals (Boston, MA)
- …with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with global ... on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent … more
- Gilead Sciences, Inc. (Washington, DC)
- …together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with ... development and regulatory path for combination products and devices. . ** Global Regulatory Excellence** Lead the development of global CMC regulatory… more
- Danaher Corporation (Deer Park, IL)
- …this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product ... position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote. In this role, you will have the… more
- Sanofi Group (Morristown, NJ)
- …GSS filing plans for Sanofi R&D's priority growth assets. + Represent GRO on the Global Regulatory Teams for Sanofi GBU priority assets, per the GRA BluePrint ... Accountable for the delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority… more