This is what you will do: Position Summary The Manager of Global Regulatory Affairs Chemistry, Manufacturing.... Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC...
Manager, Regulatory Affairs - CMC Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Manager of Regulatory Affairs - CMC to join our Regulatory Affairs...
to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects.... Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up...
Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role) Proclinical is seeking a Project... Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The successful candidate will provide high...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.../review of all regulatory submissions in support of submission readiness for small molecule, biologics, and medical devices...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the... preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics...
. We are looking for a dynamic and experienced Senior Manager, Project Management in Chemistry, Manufacturing, and Controls (CMC) to join our growing... expertise in CMC project management, strong leadership skills, and a solid understanding of regulatory requirements in the...
, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
." Who we are looking for Purpose Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post... functional teams in obtaining the necessary CMC documentation in support of a regulatory submission. Assist in the development...
Job Description General position summary: The Director CMC Compliance provides strategic leadership and quality... oversight of the GMP/GDP Regulatory Intelligence and Surveillance space for small molecule, biologics and devices/combo devices...
management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related... of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Global Medical Program Manager...
Job Description This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible... for supporting the cross-functional project teams executing our CMC and manufacturing strategies within our Povetacicept (POVE...
Job Description: The Manager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations... team and is responsible for providing support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance...
The Manager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations team... and is responsible for providing support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management. This role...
JOB TITLE: Manager/Senior Manager Biologics Drug Product DEPARTMENT: Technical Operations/Biologics CMC REPORTS...: The Manager or Senior Manager Biologics Drug Product will be responsible for all aspects of drug product process...
Industry: Pharmaceuticals Title: Quality Assurance Operations Manager Job ID: 2025-8807 Location: Cambridge... onsite preferred but open to remote (can sit anywhere in US). Remote workers will work EST time zone. Overview The Manager...
with cross-functional teams to integrate nonclinical, clinical, regulatory, and CMC activities across all stages of development...R&D PROJECT MANAGER Incendia Therapeutics is a precision oncology company dedicated to reprogramming the tumor...
, through registration, clinical trials, and commercial launch Advanced knowledge of cGMPs and associated CMC regulatory...Job Description General Summary: The Package Engineering Senior Manager is an emerging professional within the...
to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for clinical... with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination...
Job Description General Summary: The Clinical Supply Chain Manager is responsible for forecasting, packaging... as primary point of contact with contract manufacturing partners Forecasting supply needs in conjunction with Clinical and CMC...