- Sumitomo Pharma (Boston, MA)
- …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...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** As a **Principal Regulatory Affairs Specialist** at Medtronic, you will play a critical role in ... **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing responsibility. + Strong leadership… more
- Parexel (Boston, MA)
- …for NCEs and biologics * Deep knowledge of FDA , ICH, and global regulatory frameworks * Experience with international clinical trials and regulatory ... **Join Parexel as a Regulatory Affairs Strategy Lead** Are you...programs from early development through approval * Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the future ... miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization...+ Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators… more
- Parexel (Boston, MA)
- …and approved programs, helping to shape the future of life-saving therapies. As a **CMC Regulatory Affairs Senior Associate** , you will play a critical role in ... discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. + Proven… more
- Bausch + Lomb (Boston, MA)
- …degree or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …directly for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research or other critical DFCI-developed ... for the Institutional IND portfolio managed by the CTO Regulatory Affairs Core. The Institutional IND RC...regulatory experience required. Must have expert knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical… more
- Orchard Therapeutics (Boston, MA)
- …or PhD in a scientific discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning US regulatory science ... with the Agency are coherent across programs. The ED Regulatory Science will be able to predict/anticipate FDA... Clinical department (including Clinical Science, Clinical Operations, Data Management, Biostatistics, Medical Affairs ,… more