Executive- DRA

1 week ago

Pune, Maharashtra, India Sava Healthcare Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Key Responsibilities:

  • Preparation of regulatory dossiers in eCTD format for Europe (hands-on experience in eCTD is a must).
  • Thorough understanding and working knowledge of EU regulatory procedures including DCP (Decentralized Procedure) and MRP (Mutual Recognition Procedure).
  • Compilation and submission of regulatory dossiers for ROW (Rest of the World) markets.
  • Coordination and preparation of responses to deficiencies/queries received from Regulatory Agencies.
  • Application of ICH and EU regulatory guidelines during dossier preparation and submission.
  • Preparation and submission of variation packages for approved products in compliance with applicable regulations.

Desired Profile:

  • Bachelors/Master's degree in Pharmacy or Life Sciences.
  • 2–5 years of relevant experience in Regulatory Affairs with proven expertise in eCTD dossier preparation.
  • Good knowledge of EU regulatory environment and ROW regulatory requirements.
  • Strong analytical, documentation, and communication skills.
  • Ability to work independently as well as in cross-functional teams.

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