- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …+ Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC ) for investigational and commercial products ... leadership and oversight to the development of innovative regulatory affairs and CMC ...Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for… more
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and response to regulatory health authorities. + Leads the development of global CMC regulatory science-based strategies for internal RCM oncology ... Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be...Quality teams, contract manufacturing organizations, external experts, collaborators, and global health authorities. **In this role, a typical day… 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
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... part of the Corporate Strategy Office and actively supports global Business Development (BD) goals by sourcing and assessing...acquire assets. The group is responsible for leading the global search efforts for assets of high strategic value… more