Executive, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad City, Gujarat, India ·
- Employment
- Full time
- Category
- Legal
- 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.
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years