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