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Genedrift is expanding its Regulatory Affairs team and inviting skilled RA professionals experienced in injectables, medical devices, biosimilars, vaccines, and biologicals. If you have hands-on regulatory experience and a strong understanding of global compliance requirements, this is an excellent opportunity to join a fast-growing organization in the pharmaceutical sector.
This job update is ideal for candidates searching for:
Regulatory Affairs jobs in India, RA Executive openings, injectables regulatory jobs, or biosimilar regulatory affairs roles.
🔹 Key Responsibilities
- Prepare, review, and submit regulatory documentation for injectables, biologicals, biosimilars, vaccines, and medical devices.
- Ensure timely submissions for domestic and international markets.
- Coordinate with cross-functional teams to maintain regulatory compliance.
- Support new product registrations, variations, renewals, and post-approval updates.
- Maintain up-to-date knowledge of evolving regulatory guidelines (ICH, CDSCO, USFDA, EMA).
- Assist in regulatory strategy planning and dossier readiness.
🔹 Required Qualifications
- B.Pharm or M.Pharm (mandatory).
- 2–5 years of core experience in Regulatory Affairs.
- Strong hands-on exposure to:
- Injectables
- Biological products & biosimilars
- Vaccines
- Medical devices
- Understanding of CTD, ACTD, eCTD formats.
- Excellent documentation and compliance skills.
🔹 Benefits
- Opportunity to work on cutting-edge biological and injectable products.
- Growth-oriented environment with strong learning exposure.
- Competitive industry-aligned compensation.
- Work with cross-functional scientific and regulatory experts.
🔹 How to Apply
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