20/07 Harika Namburi
HR at Aurobindo Pharma

Views:292 Applications:19 Rec. Actions:Recruiter Actions:1

Regulatory Affairs Role - Post Approval - US Market (2-8 yrs) Premium

Hyderabad Job Code: 22517

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.

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