Industry: Pharmaceutical / Healthcare
Experience: 1–3 Years
Qualification: B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences)
Location: Rai Sonipat
Key Responsibilities
- Prepare and review regulatory dossiers and submission documents.
- Handle CTD/eCTD submissions, renewals, variations and registrations.
- Coordinate with CDSCO, State FDA and other regulatory authorities.
- Respond to regulatory queries and maintain authority communication.
- Coordinate with QA, R&D;, Production and Pharmacovigilance teams.
- Track regulatory updates and ensure compliance with applicable guidelines.
- Maintain regulatory records, databases and documentation.
Key Skills
- Regulatory Submissions (CTD/eCTD)
- Dossier Preparation & Review
- Knowledge of Indian & Global Regulatory Guidelines
- Health Authority Communication
- Documentation & MS Office
- Attention to Detail and Time Management
Pay: ₹241,761.71 - ₹1,184,485.78 per year
Work Location: In person
📌 Drug Regulatory Affairs Executive (India)
🏢 grecian pvrt
📍 India
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