Executive, Regulatory Affairs
Refined job description
ROLE
– Perform preliminary review of change cases in accordance with ICH quality and post‑approval USFDA guidance.
– Draft the Annual Report with required submission data as per USFDA guidance.
– Conduct preliminary review of the entire regulatory submission package.
– Ensure timely drafting and compilation of regulatory submissions to avoid delays.
– Coordinate with cross‑functional teams to obtain documents required for the regulatory submission plan.
– Maintain regulatory information as assigned.
– Draft and conduct preliminary review of Regulatory CTD modules.
REQUIREMENTS
– Good knowledge of ANDA submission activities, post‑approval procedures, and related ICH and USFDA guidelines.
– Exposure to sterile dosage forms/complex injectable dosage forms and their manufacturing processes, including key regulatory aspects.
– Ability to perform preliminary reviews of change cases and submission packages.
– Awareness of post‑approval submission guidelines and procedures for Annual Report, CBE‑0, CBE‑30, and PAS filings.
– Understanding of FDA recommendations on commercial marketing status notification submissions, including content and timelines.
– Strong coordination skills with cross‑functional teams.
– Proficiency in drafting and reviewing regulatory CTD modules.
Full job description
Description:
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
Exposure of the
Sterile dosage form / complex injectable 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.