- Takeda Pharmaceuticals (Cambridge, MA)
- …promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject ... in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review … more
- Boehringer Ingelheim (Athens, GA)
- …control strategies for chemical, biotech and vaccine products. The incumbent may serve as a Global Regulatory Project Lead within the project core team or ... is responsible for providing new product and marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls… more
- Lundbeck (Deerfield, IL)
- …in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end- to- ... Director US Regulatory Global Strategic Labelling Requisition ID:...in an optimal and compliant manner. **ESSENTIAL FUNCTIONS:** + Lead development of labelling strategy for new products and/or… more
- Amgen (Washington, DC)
- … policies that impact Amgen's business and will serve as a US Policy Lead for Global Regulatory Policy and Intelligence. Key Responsibilities include: ... will do** Let's do this. Let's change the world. Global Regulatory Policy team engages regulators, industry...goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and capability-building initiatives. + Support inspection readiness and contribute to successful global regulatory submissions. + Lead strategic planning for ... providing expert input on safety strategy, protocol design, and regulatory interactions. + Prepare and lead Safety...to work in matrixed environments + Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).… more
- EchoStar (Germantown, MD)
- …TV, Gen Mobile, Hughes and Sling TV. **Department Summary** The Sr. Director, Aviation Regulatory Engineering will lead global efforts to secure ... in LEO and GEO satellite systems + Proven track record of securing global regulatory approvals for inflight connectivity or similar services **Skills and… more
- Caris Life Sciences (Phoenix, AZ)
- …external requirements (FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks). + Lead investigations for Quality Events, ... issued are identified, resolved, and prevented in alignment with regulatory and internal Quality Systems requirements. The Analyst partners cross-functionally… more
- Stryker (Mahwah, NJ)
- …time zones and cultures to achieve market access in alignment with global regulatory requirements. **What You Will Do** + Lead development and execution of ... you will provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals for new… more
- Terumo Neuro (Aliso Viejo, CA)
- …and contribute into developing, editing, or revising regulatory processes. + Lead training for global regulatory processes and system implementations. ... partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives. + Identify regulatory requirements… more
- ThermoFisher Scientific (Washington, DC)
- …with a proven track record for successful negotiations with Health Authorities. Wider global regulatory knowledge is an advantage. + Ability to lead ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...in the future. **About the role:** The **Sr Director, Regulatory Strategy** will be responsible for advising clients on… more