- Fresenius Medical Center (Waltham, MA)
- …of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... the pharmaceutical industry. + Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing ... CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …to support cultural change and position RA team as solution providers. + Own regulatory strategy to ensure all Pharmaceutical Systems (PS) products meet ... Advanced degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance support) critical to ... Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback Statue, False Claims… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and regulatory science. The Director for AI/ML Innovation in Pharmaceutical Manufacturing will define and execute a multi-year strategic roadmap for delivering ... and regulatory return on investment for leveraging AI/ML in pharmaceutical manufacturing processes. + Support AMT's development roadmap through 2030 by… more
- Takeda Pharmaceuticals (Boston, MA)
- …technical expertise but across Takeda competencies. + Independently leads development of strategy and plans for multiple, complex programs + Regularly leads and ... influences functional/divisional strategy , operations and innovation + Functional thought leader and...Acumen** **:** + Provides scientific leadership and innovation in pharmaceutical research and development. Builds teams across functions and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …for our employees. Regulatory Expertise: The Fellow will develop basic regulatory strategy expertise/knowledge in one or more therapeutic areas. Interact ... and RA sub-team, provide leadership in the development and implementation of US regulatory strategy within a global development context. + Assess US strategic… more
- Sanofi Group (Morristown, NJ)
- …in the pharmaceutical or biotechnology industry, including 5-6 years in regulatory affairs with significant experience in labeling strategy . + Experience ... + Provide regulatory labeling leadership to cross-functional teams ( Regulatory Strategy , Clinical Development, Medical Affairs, Pharmacovigilance, Market… more
- Cardinal Health (Charleston, WV)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... Legal function. **_Job Summary_** The Assistant General Counsel - Specialty Pharmaceutical Distribution will be responsible for providing exceptional legal advice… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports,… more