Executive / AM - Regulatory Affairs (Formulation)

Roles and Responsibilities

1. In the Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule) /Parenteral formulation.
2. Should have knowledge of eCTD format for US/Europe and other regulatory agencies.
3. Responding to the ANDA deficiency.
4. Review of CMC section of drug substance for ANDA submission.
5. Submission of Post-approval changes (viz. PAS, CBE-0, CBE-30).
6. Review of Bioequivalence study protocol and report.
7. Submission of Annual report/PADER to FDA.
8. Knowledge in eCTD software & also have knowledge of DMF.

Interested candidate can also share their CV at anil.patel@apotheconpharma.com