Regulatory Affairs Executive

Roles and Responsibilities

• Prepare dossiers, variations, renewals, and amendments for regulatory submissions.
  
• Coordinate with CTD/eCTD vendors for preparation of dossiers.
  
• Review artwork, labeling, and specifications for regulatory compliance.
  
• Maintain master files and variation records according to ICH guidelines.
  
• Ensure timely submission of applications to relevant authorities.
  

Desired Candidate Profile

• 3-6 years of experience in Regulatory Affairs (dossier preparation & submission).
  
• Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution.
  
• Strong understanding of Life Cycle Management (LCM), Product Lifecycle Management (PLCM), OSD regulations.