Lifescience Intellipedia For Regulatory Affairs Dept
Position: Senior Executive – Drug Regulatory Affairs
Location: C-89, C Block, Sector 65, Noida, Uttar Pradesh – 201301
Job Type: Full-time, On-site
Role Summary: The selected candidate will be responsible for managing regulatory affairs for pharmaceutical and food industry clients, ensuring compliance, documentation accuracy, and efficient submission processes across national and international guidelines.
Key Responsibilities:
- Understand client-specific regulatory requirements
- Compile, review, and perform GAP analysis of CTD/ACTD and country-specific dossiers
- Respond to MOH queries and complete final submissions
- Prepare quality documents including CDP, PDE reports
- Compile and register food dossiers for export
- Coordinate cross-functionally with QA, QC, R&D, and Production teams
- Manage e-submissions through SUGAM, Nivesh Mitra, and FSSAI-FoSCoS
Required Qualifications & Skills:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- 3 to 5 years of hands-on experience in drug regulatory affairs
- Strong knowledge of CTD, ACTD, ICH Guidelines, and eCTD
- Familiarity with regulatory databases and portals
- Proficient in documentation and communication
- Understanding of audit and inspection protocols and current regulatory trends
How To Apply: Send your resume to: hr@lifescienceintellipedia.com
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| Lifescience Hiring For Regulatory Affairs Dept |
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