Assistant Manager, Regulatory Affairs
Assistant Manager, Regulatory Affairs
Refined job description
ROLE
– Review change cases in accordance with ICH quality and post‑approval USFDA guidance.
– Prepare and submit controlled correspondence.
– Review and compile Annual Reports with required submission data per USFDA guidance.
– Review and compile complete supplement/amendment submission packages.
– Ensure compliance with FDA recommendations for commercial marketing status notification submissions, including content and timelines.
– Coordinate with cross‑functional teams to obtain documents according to the regulatory submission plan.
– Prevent delays in drafting and compiling regulatory submissions.
– Maintain regulatory information as assigned.
– Draft and review regulatory CTD modules.
REQUIREMENTS
– Good knowledge of US ANDA submission activities, post‑approval procedures, and related ICH and USFDA guidelines.
– Exposure to solid oral, liquid oral, transdermal, topical‑inhalation dosage forms and their manufacturing processes and key regulatory aspects.
– Understanding of post‑approval submission guidelines and procedures for Annual Report, CBE‑0, CBE‑30, and PAS filings.
– Awareness of FDA recommendations on commercial marketing status notification submissions.
– Ability to coordinate with cross‑functional teams and manage document availability.
– Strong drafting and review skills for regulatory CTD modules.
– Familiarity with regulatory information maintenance tasks.
Full job description
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 and PAS filling
Preparation and submission of controlled correspondence
Review and compilation of Annual
Report
with required submission data as per USFDA guidance.
Review
and compilation of entire supplement/amendment 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 & review skills.