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Officer / Executive / AM - RA [Formulation]
Apothecon Pharmaceuticals Pvt. Ltd.
Full time
2+ years
Not Disclosed
Ankleshwar, India
Post Date: Apr 10, 2024
End Date: Jun 10, 2024
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2+ years
Not Disclosed
Ankleshwar, India
Post Date:Apr 10, 2024
End Date: Jun 10, 2024
Skills:
Drug Safety
Regulatory Affairs
Management
Job Description:
Responsibilities
In the Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule) /Parenteral formulation.
Should have knowledge of eCTD format for US/Europe and other regulatory agencies.
Responding to the ANDA deficiency.
Review of CMC section of drug substance for ANDA submission.
Submission of Post-approval changes (viz. PAS, CBE-0, CBE-30).
Review of Bioequivalence study protocol and report.
Submission of Annual report/PADER to FDA.
Knowledge in eCTD software & also have knowledge of DMF.
Job Overview
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Salary
Not Disclosed
Role
Executive or Officer
Area of Practice
Regulatory Affairs
Experience
2+ years
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