Regulatory Affairs Officer

Roles and Responsibilities

• Prepare dossiers for regulatory submissions, including CTD/eCTD format preparation.
  
• Coordinate with cross-functional teams (QA, QC, Marketing) to obtain necessary documents for dossier compilation.
  
• Ensure compliance with regulatory requirements by reviewing documents such as SOPs, protocols, reports, and batch records.
  
  
• Review and compile dossiers according to client specifications and timelines.
  
• Maintain accurate records of all activities related to dossier compilation.
  

Desired Candidate Profile

• 2-4 years of experience in Regulatory Affairs or a related field (B.Pharma / M.Pharma).

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• Strong knowledge of drug regulatory affairs in the Row market (European region).
  
• Proficiency in dossier preparation using CTD/eCTD formats.
  
• Excellent understanding of regulatory guidelines from various regions (USFDA, EMA, ANVISA etc.).
  
• Ability to work independently with minimal supervision.