Role & responsibilities

- Prepare, review, and compile CMC documentation (Modules 2 & 3) for pharmaceutical formulation products.

- Compile and maintain CTD/eCTD dossiers for initial registrations, variations, renewals, and post-approval submissions.

- Review GMP documentation and Active Substance Master Files (ASMF/DMF).

- Support regulatory submissions and responses to Health Authority queries for European markets.

- Ensure dossiers comply with EMA, MHRA, and other applicable regulatory guidelines.

- Provide regulatory support to cross-functional teams throughout the product lifecycle.

- Coordinate with regulatory authorities and external Partners, as required.

- Identify regulatory risks and ensure timely compliance with evolving global regulations.

Preferred

Qualifications

- Hands-on experience in CMC documentation, CTD/eCTD dossier preparation, and lifecycle management.

- Robust knowledge of European regulatory requirements

- Excellent documentation, analytical, and communication skills.

Preferred candidate profile

- B.Pharm

- M.Pharm (especially Pharmaceutics or Regulatory Affairs)

- B.Sc./M.Sc. in Life Sciences (with relevant regulatory affairs experience)

📌 Regulatory Affairs Executive (Vadodara)
🏢 Novumgen
📍 Vadodara