Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals
- 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 good Regulatory CTD modules drafting & review skills.
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 8 years or more in 8 - 10 Years