Executive - Regulatory & Scientific Affairs

Executive to Sr. Executive Regulatory & Scientific Affairs (Formulations)

Department: Regulatory & Scientific Affairs
Location: Vadodara, Ahmedabad

Job Summary:

We are seeking a Regulatory & Scientific Affairs professional with experience in pharmaceutical formulations to support regulatory submissions and lifecycle management for European and UK regulated markets. The role involves CMC dossier preparation, regulatory documentation, and ensuring compliance with global regulatory requirements.

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.
• Strong knowledge of European and UK regulatory requirements (EMA/MHRA).
• 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)