Hiring Regulatory Affairs Officer / Executive / AM - RA [Formulation]
Must have exposure on US / Europe Markets 🙂
Roles and 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.
Do share the profiles on Anil.patel@apotheconpharma.com
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