Regulatory Affairs Assistant Manager

Roles and Responsibilities

• Manage regulatory dossiers (eCTD) submission for ANDA, DMF, and other products.
  
• Coordinate with cross-functional teams to ensure timely submission of regulatory applications.
  
• Review and manage variations, renewals, extensions, and post-marketing requirements.
  
  
  
• Prepare and review CTD modules for marketing authorizations.
  
• Ensure compliance with FDA regulations and guidelines.
  

Desired Candidate Profile

• 8-13 years of experience in Regulatory Affairs or related field.
  
• B.Pharma degree from a recognized institution.
  
• M.Pharma degree preferred but not mandatory.
  
• Strong understanding of drug regulatory affairs, injectables, and US market knowledge.