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Regulatory Affairs CMC

2 weeks ago

Hyderabad, Telangana, India Aurobindo Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers.
  • 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).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines.
  • Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports,
  • Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages.
  • Formulate US regulatory filing strategy for new projects.
  • Preparing quarterly and monthly targets. Allotting and evaluating targets of the team.

Good interpretation skill for ICH and FDA guidelines