The Director Regulatory CMC supports development programs. Functions independently with minimal supervision as a core... CMC Develop and lead the execution of regulatory CMC investigational, registration, and post-approval strategies...
Position Title: Director, Regulatory, CMC Reports to: ED, Regulatory Affairs Location: Hybrid, Princeton, NJ PMV... is seeking an experienced and motivated Director of Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) to lead the...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director... requirements. Knowledge/experience with CMC regulatory requirements....
PMV Pharma is seeking an exceptional Director of CMC Project Management to oversee and manage Chemistry, Manufacturing... related documents. Coordinate the preparation of high-quality regulatory submissions as needed. Assist the CMC technical...
SUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines..., policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory...
of development, and are released in a timely manner. Collaborate with CMC, Clinical Supplies Management, Regulatory Affairs... plans specifically supporting GMP activities. Review CMC sections of global regulatory submissions to ensure consistency...
, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role... filings Initiate and coordinate the preparation of CMC documentation Collaborate with Regulatory Affairs and other groups...
, Medical, Regulatory, CMC, Commercial, and Project Leadership to help optimize overall development strategy; as well as to help... lives. Read more: . Summary: The Director will serve to help maximize the value in Psychiatry and Neuroscience...
, Regulatory, CMC, Commercial, and Project Leadership to help optimize overall development strategy; as well as to help prepare... lives. Read more: . Summary: The Director will serve to help maximize the value in Psychiatry and Neuroscience...
; and Development, Medical, Regulatory, CMC, Commercial, and Project Leadership to help optimize overall development strategy; as well... lives. Read more: . Summary: The Director will serve to help maximize the value in Psychiatry and Neuroscience...