
Executive- DRA
1 week ago
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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