Regulatory Affairs (EU/USA/Brazil / ROW / LATAM

Roles and Responsibilities

• Manage regulatory dossiers for EU, USA, Brazil, ROW & LATAM regions.
  
• Prepare compilation documents for product variations including STPs, IBs, PSUs, PMHFAs etc.
  
• Ensure timely submission of dossiers to concerned authorities through respective portals.
  
• Coordinate with cross-functional teams for preparation of dossiers and follow-up on submissions.
  
• Maintain accurate records of all submitted documents and track progress.
  

Desired Candidate Profile

• 5-8 years of experience in Regulatory Affairs with expertise in Life Cycle Management.
  
• Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma) from a recognized institution.
  
• Strong understanding of pharmaceutical regulations governing different regions such as EU GMP/Gxp guidelines, FDA CFR21 Part 210/820 requirements for USA market approval.