Regulatory Affairs Executive

Novumgen; Vadodara; On-site; INR 750,000 - 1,200,000; Full time

Job summary

Novumgen in India seeks a regulatory affairs specialist to prepare, review, and compile CMC documentation (Modules 2 & 3) and manage CTD/eCTD dossiers for regulatory submissions across European markets. You will review GMP docs and ASMF/DMF, supporting Health Authority queries and ensuring EMA/MHRA guideline compliance.

Collaborating with cross-functional teams, you will identify regulatory risks and coordinate with authorities and external partners to ensure timely market access for European

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.

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.

Skills

CMC documentation

CTD/eCTD

Regulatory affairs

Documentation skills

Education

B.Pharm

M.Pharm

B.Sc./M.Sc Life Sciences

Job description

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)