Senior Regulatory Affairs Specialist

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.