- Otsuka America Pharmaceutical Inc. (Concord, NH)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- Parexel (Concord, NH)
- … regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary ... to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Sumitomo Pharma (Concord, NH)
- …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....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Otsuka America Pharmaceutical Inc. (Concord, NH)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... **Job Summary** The Senior Director will serve as the Translational Medicine...Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC , and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …colleagues from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and ... of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays +… more