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Regulatory Affairs Specialist II
About the role
Regulatory Affairs team at Bio-Rad India ensures product registrations and compliance across India and neighboring markets. The role coordinates RA and QA activities, maintains regulatory systems, supports submissions, and drives quality management per ISO standards. Gurgaon, India, on-site, 1 opening.
What you’ll do
- Direct and organize RA/QA activities across India and neighboring countries
- Ensure product registrations and maintain compliance records with authorities
- Maintain regulatory system updates and Veeva Vault data
- Support QMS implementation per ISO 9001, 13485, 14001
- Coordinate submissions, variations, renewals and post‑market vigilance
- Assist with customer notifications, recalls and corrective actions
- Support tender submissions with regulatory and quality documents
- Liaise with internal teams and regulatory authorities
What you’ll bring
B.Pharm or M.Pharm or B.Tech in pharmacy
Nice to have
- 4-6 years experience in multinational organization
- 5 years RA and QA experience in regional sales and distribution
- Hands‑on SAP for RA/QA
- Experience with Veeva Vault RIMS
Skills
Benefits
- Competitive insurance plans
- Annual health checkup
- Marriage and paternity leave
- Employee assistance programme
- Learning and development opportunities