RA Lead- Regulatory Affairs, SQR
BengaluruFull-timeSenior levelPosted over a month ago
Senior pharma role at INSC IND GBS India in Bengaluru.
About the role
Build, lead and develop a high-performing Regulatory Affairs team-recruitment, onboarding, coaching, performance management and succession planning, in partnership with global SQR leadership and GBS enabling functions
What you'll do
- Build, lead and develop a high-performing Regulatory Affairs team-recruitment, onboarding, coaching, performance management and succession planning
- Prepare and maintain technical documentation under EU MDR 2017/745 and IVDR 2017/746, including inputs to clinical evaluation and post-market surveillance documentation
- Support U.S. FDA submissions (510(k), pre-submissions, letters to file) and international country registrations, license renewals and legalisation requirements
- Assess design, labeling and manufacturing changes for regulatory impact and determine notification and submission requirements together with R&D, Quality and Operations
- Own regulatory data governance and data quality in RIM and related systems, ensuring completeness, accuracy and audit readiness of registration and licence records
What you need
- Regulatory affairs
- Documentation
- Performance management
- Talent management