Lead Specialist Regulatory Affairs
Bengaluru, KalyaniFull-time6–8 yrsPosted 3 weeks ago
Senior pharma role at GE HealthCare in Bengaluru and Kalyani. Needs 6–8 years and a B.Tech or B.E..
About the role
The Regulatory Affairs supports regulatory activities for assigned products and markets throughout the product lifecycle.
What you'll do
- Provide global RA support for registration planning, submissions, notified body and quality system audits, and program implementation
- Contribute to writing and editing technical documents and research, analyze, integrate, and organize information from diverse sources for regulatory submissions
- Support development of practical go-to-market strategies by identifying regulatory requirements, constraints, dependencies, and timelines, and escalating concerns early
- Monitor changes to applicable regulations and standards and assist in assessing potential impact on assigned products, markets, documentation, and regulatory commitments
- Develop and maintain working technical knowledge of assigned products, including intended use, design and performance characteristics, manufacturing context
What you need
- Regulatory affairs
- Documentation
- Communication
- Go-to-market
- Product knowledge