Executive, Regulatory Affairs
Executive, Regulatory Affairs
Refined job description
ROLE
– Perform preliminary review of change cases with respect to ICH quality and post‑approval USFDA guidance.
– Draft Annual Reports with required submission data as per USFDA guidance.
– Conduct preliminary review of entire submission packages.
– Draft controlled correspondence/briefing packages to FDA for assigned projects.
– Coordinate with cross‑functional teams to ensure document availability according to the regulatory submission plan.
– Ensure timely drafting and compilation of regulatory submissions.
– Maintain regulatory information for allocated tasks.
– Draft and perform preliminary review of regulatory CTD modules.
REQUIREMENTS
– Good knowledge of ANDA submission activities, post‑approval procedures, and related ICH and USFDA guidelines.
– Experience reviewing API DMF and DMF Change Notifications in accordance with USFDA regulatory requirements.
– Exposure to solid oral, sterile, complex, topical‑inhalation dosage forms and understanding of their manufacturing processes and key regulatory aspects.
– Ability to conduct 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.
– Proficiency in drafting Annual Reports, controlled correspondence, and briefing packages.
– Knowledge of FDA recommendations on commercial marketing status notification submissions, including content and timelines.
– Strong coordination skills with cross‑functional teams.
– Good regulatory CTD module drafting and preliminary review skills.
Full job description
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
API DMF and DMF Change Notification 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.