protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team...: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies...
Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead.... Global regulatory experience is required, and immunology background is preferred. CMC experience is a plus. Responsibilities...
and modest costs. Description of Role The Executive Director, Regulatory CMC will provide strategic leadership for global CMC.... Work Location The Executive Director, Regulatory CMC role is a remote role based in the US, with occasional travel...
and modest costs. Description of Role Our Associate Director, Regulatory Affairs Reporting will be responsible for performing... Director, Regulatory Affairs, you will act as the regulatory lead on project teams, providing regulatory guidance and oversight...
and manufacturing process; ensures timely closure of such investigations Partner with Quality Assurance and CMC Regulatory Affairs SMEs... and other presentations . About the Role Senior Director, CMC Drug Substance Development & Manufacturing Reporting to the SVP of CMC...
, and data generated by external laboratories meet Vertex, global regulatory, and data integrity standards. Key Duties... product programs. Collaborate with CMC, Analytical Development, QC, MS&T, Device Engineering, QA Device, and Regulatory...