Senior Executive- Drug Regulatory Affair

Company Description

Lifescience Intellipedia is the fully data-integrated solutions and services provider for all life sciences industries, including Pharma, Veterinary, Agro, Cosmetics, Specialty Chemicals, Dyes & Pigments, Biotech, and Polymer. Our vision is to create a robust information system for all life science industries in one place. We offer an online buyer and supplier database called Chemxpert, market research services, and regulatory services to ensure compliance with country-specific guidelines. Our forward and backward integrated solutions add value to professionals involved in R&D, Procurement, Business Development, Sales, and Market Research within all spheres of the life sciences industries.

Role Description

This is a full-time, on-site role located in Noida, India for a Senior Executive-Drug Regulatory Affairs. • • --

• Understanding of Client Regulatory Requirement

• Compilation, Review, GAP Analysis of CTD, ACTD and Country Specific Dossiers and respective Quality Documents.

• MOH Query Review, Resolution and Final Deliveries for the same.

• Compilation of the Specific Quality Reports- CDP Report, PDE Reports, etc.

• Compilation, Review and final submission for the Food Dossiers for Export Registration.

• MOH Query Resolution for the Food Dossiers as per country specific guidelines.

• Experience with eCTD will be an added advantage.

• Hands on experience in review and compilation of all Modules (as per CTD & ACTD FORMATS)

Familiar with ICH Guidelines.

• Able to coordinate with cross functional teams QA, QC, R&D and Production for technical documents

• required for Regulatory publishing and submission.

• Handling of the Online Submissions via SUGAM, NIVESH MITRA, FSSAI-FosCos, etc.

Qualifications & Skills

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field
• Proficiency in maintaining regulatory databases
• Strong communication and documentation skills
• Ability to stay updated with regulatory changes and guidelines
• minimum 3-5 yrs of Experience in providing regulatory guidance and support to project teams
• Knowledge of audit and inspection processes
• Experience in the life sciences industry is a plus

How to apply

send your updated CV on hr@lifescienceintellipedia.com

reach us- +91-9599069079

Concern Person- Ms. Ifra Fatimah & Mr. Awadhesh Kumar

HR Department