Executive, Regulatory Affairs
• Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. • API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. • Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. • Ability to preliminary review the change cases with respect to ICH quality / post approval...