Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
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.
Awareness about the FDA recommendation on the commercial
marketing status notification
submission in terms of content and time frames and submissions.
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.