Responsible for the preparation, review, and lifecycle management of DMFs, ASMFs, and CEPs for global regulatory submissions (USFDA, EDQM, and ROW), including post-approval changes, annual reports, and eCTD publishing. Ensures regulatory compliance through review of CMC documentation, effective customer communication, and cross-functional coordination to support product registrations and regulatory commitments.
Formulation:
Responsible for the preparation, review, and submission of regulatory dossiers (NDA, ANDA, EU, and ROW) in CTD/eCTD format, including deficiency responses and lifecycle management activities. Managing post-approval changes and coordinating with cross-functional teams to ensure timely approvals Role & responsibilities