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Teva Pharmaceuticals Recruitment Sr Mgr Regulatory Affairs For MPharma apply now

Vacancy details:
  • Post Name: Sr Mgr Regulatory Affairs
  • Qualification: M.Pharma
  • Experience10-12 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).
Important details: 
  1. Location: Navi Mumbai
  2. Salary : Not Disclosed by Recruiter
  3. Openings : NA
Selection ProcessThe selection will be on the basis of Interview.
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