Regulatory Affairs Executive

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.
• Strong 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)