Senior Regulatory Affairs Specialist
GurugramFull-time3–5 yrsPosted over a month ago
Mid-level pharma role at CooperCompanies in Gurugram. Needs 3–5 years.
About the role
Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal, ensuring compliance with applicable local regulatory requirements. Act as the primary regulatory liaison with external consultants, distributors, and local health authorities, coordinating all regulatory‑related communications, submissions, responses, and follow‑ups.
What you'll do
- Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal
- Act as the primary regulatory liaison with external consultants, distributors, and local health authorities, coordinating all regulatory‑related communications
- Ensure timely progression of regulatory activities, proactive issue resolution
- Provide regulatory input and guidance for assigned countries on regulatory‑related matters
- Ensure product registrations are reviewed, maintained, and renewed in accordance with local regulatory requirements
What you need
- Regulatory affairs
- Documentation