- Eisai, Inc (Boston, MA)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Unknown (Boston, MA)
- …CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC, with experience leading regulatory strategies and ... expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in… more
- Merck & Co. (MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... could be critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs - Advertising and Promotion, you'll partner with other… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
