- Lilly (Washington, DC)
- …regulatory risk, and improve efficiency in drug development. The purpose of the Sr . Director - GRA Global Regulatory Policy & Strategy - Oncology role is ... Positions and External Engagement Strategies** + Gain consensus on Lilly's priority global regulatory topics consistent with GRA 's overall regulatory policy… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ( GRA -CMC) leads and manages the scientific and ... into regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central...leads the Global Regulatory Team (inclusive of GRA central functions, GRA -CMC, GRA -Devices,… more
- Sanofi Group (Cambridge, MA)
- …Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products ( Sr . Director ) **Location** : Cambridge, MA or Morristown, NJ **About ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs ( GRA ) Device Head, Specialty Care Device and Combination Products will… more
- Takeda Pharmaceuticals (Lexington, MA)
- …worldwide. **How you will contribute:** This role is within in the R&D GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to ... regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically… more
- Lilly (San Francisco, CA)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) ... Accordingly, the GRL is the primary interface with, and will represent GRA on global brand development/program team to ensure global input into development… more
- Boehringer Ingelheim (Ridgefield, CT)
- …lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs ( GRA ) on the Evidence Team. The Director , Global Regulatory Strategy ... benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead will provide strategic regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the solutions. + Effectively represent the Global Regulatory Affairs ( GRA ) function in senior level interactions at internally governance technical ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...health care professionals. . Working within Labeling Team and GRA - Represents Global Labeling at … more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the ... the process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...most competitive labeling possible Working within Labeling Team and GRA - Represents Global Labeling Devices at… more
- Merck (Annapolis, MD)
- …Clinical Safety (GRACS) and external to GRACS. **Key functions:** + Reports to Senior Principal Scientist ( Senior Director ) and/or Distinguished Scientist ... **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is responsible for...will independently manage projects, functioning as the single, accountable, global point of contact on those projects and interact… more