Regulatory Affairs - Formulations

Roles and Responsibilities

• Manage ANDAs (Abbreviated New Drug Applications) for US market approval.
  
• Coordinate with DMF (Dossier Management Facility) team for dossier compilation and submission.
  
• Prepare dossiers, variations, renewals, and amendments according to FDA guidelines.
  
• Ensure timely review of documents by internal teams and external agencies.
  
• Maintain accurate records of all regulatory correspondences.
  

Desired Candidate Profile

• MS/M.Sc(Science) or M.Pharma degree from a recognized institution.
  
• Strong understanding of formulation research development principles.
  
• Excellent communication skills with ability to work effectively with cross-functional teams.
  
• 0-3 years of experience in Regulatory Affairs - Formulations with expertise in drug regulatory affairs.