Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
API DMF 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 USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
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.
Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
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.
Having good Regulatory CTD modules drafting & preliminary review skills.

Senior Regulatory Affairs Specialist