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...
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...
Job Title: Intern - Regulatory Affairs, CMC (year-round) Job Location: United States Job Location Type: Remote.... Requirements The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely...
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...
Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The successful candidate will provide high...Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role) Proclinical is seeking a Project...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.... This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...
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...
." 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...
& Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives..., through registration, clinical trials, and commercial launch Advanced knowledge of cGMPs and associated CMC regulatory...
with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination... to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for clinical...
expectations and influencing others Working with cross functional team including Clinical Operations, Regulatory Affairs and QA...Job Description General Summary: The Clinical Supply Chain Manager is responsible for forecasting, packaging...
from discovery through development to address patient needs. Purpose Of The Position Within regulatory affairs and in cross... among Development team, Project team, Pharmacovigilance, Regulatory leads, Medical affairs, Commercial, Legal representatives...