Assistant Manager, Regulatory Affairs
• Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. • Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. • Ability to review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30...