- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... the greater United States, preferably East Coast** **Summary:** Responsible for providing regulatory strategic support for global regulatory activities for… more
- Danaher Corporation (Raleigh, NC)
- …Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- AbbVie (North Chicago, IL)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, ... in the assigned therapeutic area. + Responsible for leading the Global Regulatory Product Team (GRPT), developing, and implementing global strategies… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Merck (Rahway, NJ)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein… more