* Valuable 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.

📌 Senior Executive, Regulatory Affairs (India)
🏢 Amneal
📍 India