Regulatory Affairs Expert
BengaluruFull-time8–10 yrsPosted over a month ago
Senior pharma role at INSC IND GBS India in Bengaluru. Needs 8–10 years and a B.Tech or B.E..
About the role
Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards. Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements. Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes.
What you'll do
- Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
- Ensure compliance with regulatory standards and testing requirements throughout product design and development
- Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
- Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
- Coordinate regulatory product strategies
What you need
- Regulatory affairs
- Data privacy
- Documentation
- Communication