HR at Aurobindo Pharma
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Regulatory Affairs Role - Post Approval - US Market (2-8 yrs)
Department : Regulatory Affairs, US Market
Role : Post Approval
Experience : 2-8 years
Qualification : B. Pharm/M. Pharm
Job Description :
- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines.
- Adherence to high quality, and regulatory standards in dossiers.
- Review and submission of Annual Reports (ANDAs/NDAs).
- Good interpretation of FDA queries.
- Meeting agreed upon timelines.
- Excellent drafting skill.
- Ensure adherence to high safety, quality, and regulatory standards in response.
- Evaluation and good interpretation of post approval changes.
- Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).
- Review and authorizing regulatory change controls.
- Knowledge of eCTD, Module 2 and 3.
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.
