Officer - Plant Regulatory Affair Department

4 hours ago


Ahmedabad, Gujarat, India Emcure Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Roles and Responsibilities

  • Prepare dossiers for US FDA, including CTD format.
  • Ensure regulatory compliance with RA requirements.
  • Manage parenteral products' dossier preparation and submission to regulatory authorities.
  • Coordinate with cross-functional teams for injectable product development and registration.
  • Track regulatory updates and maintain records in Trackwise system.

Desired Candidate Profile

  • 1-4 years of experience in Dossier Preparation, Regulatory Affairs (RA), or related field.
  • M.Pharma degree from a recognized institution.
  • Strong understanding of drug regulatory affairs, particularly in the US market (USFDA).
  • Proficiency in preparing dossiers according to CTD format.

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