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...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director... requirements. Knowledge/experience with CMC regulatory requirements....
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...
, 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...