ROLE
– 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
– Preliminary review the change cases with respect to ICH quality / post approval USFDA guidance
– Drafting of the Annual Report with required submission data as per USFDA guidance
– Preliminary review of entire submission package
– Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects
– Coordination with Cross Functional teams for the documents availability as per regulatory submission plan
– Ensure the no delay in drafting and compiling the regulatory submission
– Maintain regulatory information as per allocated task

REQUIREMENTS
– Ability to preliminary review the change cases
– Awareness of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
– Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames
– Good Regulatory CTD modules drafting & preliminary review skills
– 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