Lifescience Intellipedia Pvt. Ltd. is a leading data-integrated solutions provider for life sciences industries, including Pharma, Biotech, Veterinary, Agro, and Cosmetics. The company offers:
- Chemxpert Database (buyer-supplier network)
- Market Research & Regulatory Compliance Services
- End-to-end regulatory support for global pharmaceutical submissions
With a vision to create a robust information system for life sciences, Lifescience Intellipedia supports professionals in R&D, Procurement, Business Development, and Regulatory Affairs.
Job Description: Senior Executive – Drug Regulatory Affairs
Location: Noida, India (On-site)
Job Type: Full-time
Experience: 3-5 years
Key Responsibilities:
✔ Regulatory Dossier Management:
- Compilation, review, and GAP analysis of CTD, ACTD, and country-specific dossiers
- Handling MOH queries, resolutions, and final submissions
- Preparation of Quality Documents (CDP, PDE Reports, etc.)
✔ Food & Pharma Regulatory Compliance:
- Compilation & submission of Food Dossiers for Export Registration
- MOH query resolution as per country-specific guidelines
✔ eCTD & Digital Submissions:
- Experience with eCTD submissions (preferred)
- Handling online submissions via SUGAM, NIVESH MITRA, FSSAI-FosCos
✔ Cross-functional Coordination:
- Liaising with QA, QC, R&D, and Production teams for technical documents
- Ensuring compliance with ICH Guidelines
Eligibility & Skills Required
✅ Education: Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field
✅ Experience: 3-5 years in Regulatory Affairs (Pharma/Food)
✅ Technical Skills:
- Strong knowledge of CTD/ACTD formats
- Familiarity with ICH Guidelines, MOH requirements
- Proficiency in regulatory databases & online submission portals
✅ Soft Skills: - Excellent communication & documentation abilities
- Ability to interpret regulatory changes
Benefits & Why Join?
🔹 Industry Exposure: Work with global regulatory frameworks
🔹 Career Growth: Opportunities in a fast-growing regulatory consulting firm
🔹 Learning & Development: Stay updated with latest compliance trends
🔹 Stable Work Environment: On-site role with structured workflows
How to Apply?
📩 Send your updated CV to: hr@lifescienceintellipedia.com
📌 Subject Line: “Application for Senior Executive – Regulatory Affairs”
