Teva Pharmaceuticals Recruitment May 2020 M.Pharma for Sr Mgr Regulatory Affairs @Navi Mumbai . Interested candidates may Apply online for selection as detailed below.
- Post Name: Sr Mgr Regulatory Affairs
- Qualification: M.Pharma
- Experience: 10-12 years experience in regulatory affairs.
Job Description: We have requirement for the post of Sr Mgr Regulatory Affairs in Teva Pharmaceuticals!
- Should be able to lead and guide regulatory team at the development site.
- Put forward regulatory strategies during development.
- Ensure the product development is as per the FDA guidances and any concerns should be highlighted and communicated to Senior RA leadership .
- Work with the various stake holders and co-ordinate to get right documents and ensure timely submissions of responses.
- Escalate issues which can delay submissions, can cause RTRs or result in suboptimal submissions
- Review of Compiled dossiers
- Perform all other regulatory activities as required by management.
- Provide Regulatory support to the Development site.
- Thorough review of documents to maintain submission quality
- Review and support compilation of ANDA documents.
- Ensure quality of ANDAs documents meet FDA requirements, so as no RTRs are received
- Highlight any regulatory issues or concerns during development
- Development Support (New Submission).
- Location: Navi Mumbai
- Salary : Not Disclosed by Recruiter
- Openings : NA
Selection Process: The selection will be on the basis of Interview.