Key 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 and UK 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.
- Excellent documentation, analytical, and Communication skills.

Education:

- B.
Pharm
- M.
Pharm (especially Pharmaceutics or Regulatory Affairs)
- B.
Sc./M.
Sc. in Life Sciences (with relevant regulatory affairs experience)

📌 Executive (Vadodara)
🏢 Novumgen
📍 Vadodara