- Kura Oncology (Boston, MA)
- …grit drive all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTIONS: The Assoc Dir/ Director , Regulatory Affairs will be responsible for developing, ... implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and hematology portfolio. The individual… more
- Leica Biosystems (Boston, MA)
- …sector.This position reports to the Director , Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote.In ... pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in… more
- Kura Oncology (Boston, MA)
- …a plus. Collaborates with the cross-functional team comprised of regulatory affairs , clinical development, clinical operations, biostatistics, pharmacology, ... edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical… more
- Zenas BioPharma (Waltham, MA)
- …KOL engagement) Manage cross-functional initiatives with teams like R&D, Commercial, and Regulatory Affairs . Facilitate collaboration between Medical Affairs ... ensuring alignment with strategic objectives. Reporting to the Senior Vice President, Global Medical Affairs , this role manages timelines, budgets, and vendor… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... communicating with regulatory agencies. Must have experience in global regulatory submission requirements and processes. Program Leadership… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
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