Pharma Job : Research Scientist @ Aurobindo Pharma
Pharma candidates apply online at Aurobindo Pharma for a research scientist position. Pharma jobs for eligible candidates at Aurobindo Pharma. Check out all of the details on the same below:
Job Title: Research Scientist
No. of Posts: 1
Job Description:
-Compilation, review and submission of various regulatory post-approval activities
-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.
Qualifications:
Desired Candidate Profile
-Should have good interpretation skills
Qualification: B.Pharm/M.Pharm
-Should have experience in Regulatory-Post approval activities
-should have computer knowledge/eCTD software knowledge
Education-
UG: B.Pharma – Pharmacy
PG:M.Pharma – Pharmacy
Doctorate:Doctorate Not Required
