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Sr Regulatory Affairs Specialist

India · Remote · Full-time · Legal

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About the role

Clinical ResearchRisk Management
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Regulatory Affairs Specialist based in India. We are seeking an experienced Regulatory Affairs Specialist to provide regulatory expertise and support clinical research activities across India and selected regional markets. In this role, you will contribute to regulatory intelligence, submission coordination, and compliance activities, ensuring alignment with local, regional, and international regulatory requirements. You will monitor evolving regulations, interpret regulatory updates, and help project teams navigate complex clinical trial requirements. Working closely with Clinical Operations, Pharmacovigilance, Drug Safety, and other cross-functional teams, you will support timely submissions and effective regulatory processes. You will also coordinate with local regulatory consultants across neighboring countries and contribute to inspection readiness and risk management. This is an opportunity to make a meaningful contribution to clinical research and patient health within a collaborative, global, and science-driven environment.