- Chiesi (Boston, MA)
- …Who we are looking for Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of ... Affairs specifically with Small Molecules focused on Regulatory CMC + Good understanding of the...drug development and life-cycle management process + Familiarity with global CMC regulations, including ICH requirements and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Merck (Boston, MA)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... system aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and...Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , … more
- Rhythm Pharmaceuticals (Boston, MA)
- …stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs . + Manages and executes activities related to drug ... will collaborate with partners in Supply Chain, Quality Assurance, Regulatory Affairs , Finance and various CRO/CMO's to...as required. + Authors and reviews relevant drug product CMC sections for global regulatory … more
- Organon & Co. (Boston, MA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more