- United Therapeutics (Boston, MA)
- … affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the… more
- Fresenius Medical Center (Waltham, MA)
- …Sciences, Pharmacy, Chemistry, or a related field (Advanced degree such as a Master's, PhD , or MBA is highly preferred). + Regulatory Affairs Certification (eg, ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- The Brattle Group (Boston, MA)
- …are completing their PhDs by the summer of 2026) as well as experienced PhD 's who have been in the workplace (consulting, government, academia, industry, or other ... to be sought after to answer some of the most important complex economic, regulatory , and financial questions for clients around the world. We are also small enough… more
- DuPont (Marlborough, MA)
- …registration statements with the US Securities and Exchange Commission, applicable regulatory approvals, and satisfactory completion of financing. _ _For further ... discussion of risks, uncertainties and assumptions that could impact the achievement, expected timing and intended benefits of the separation transactions, see DuPont's_ _announcement… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple ... efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in the department and within… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. **Management of Local Exceptions and LOC Interactions** + Manages… more
- Takeda Pharmaceuticals (Boston, MA)
- …for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and ... and digital health efforts for assigned programs.. + Ensures global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...in a relevant scientific discipline required. Advanced degree (PharmD, PhD , MD, or DVM or MSc in Biology, Life… more