Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
Post : Sr Mgr Regulatory Affairs
Job Description
• 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).
Candidate Profile
M.Pharm with 10-12 years experience in regulatory affairs.
Additional Information
Qualification : M.Pharm
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10th March, 2020
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