- 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 positive Regulatory CTD modules drafting review skills.

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Assistant Manager, Regulatory Affairs (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad