- Merck (Boston, MA)
- **Job Description** The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This… more
- 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
- Pfizer (Cambridge, MA)
- …Is What You Need (Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… 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 ... enough to be sought after to answer complex economic, regulatory , and financial questions for clients around the world....Principals and testifying experts. **Ideal Candidates Will Possess** + PhD in Economics or related field with a strong… 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)
- …in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory ... management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience… 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