Regulatory Affairs Executive / Senior Executive - LVP
HyderabadFull-timeMid levelPosted 4 months ago
Mid-level pharma role at Promea Therapeutics in Hyderabad.
About the role
Prepare, compile, and maintain regulatory and technical documentation required for Test license, product registrations, renewals, variations, amendments, site registrations, manufacturing licenses, and post-approval changes.
What you'll do
- Prepare, review, compile, and submit regulatory dossiers for pharmaceutical products, including LVPs, sterile injectables, for domestic and export ROW markets
- Handle regulatory submissions through CDSCO, State DCA, and international regulatory portals in accordance with applicable regulatory requirements
- Prepare, compile, and maintain regulatory and technical documentation required for Test license, product registrations, renewals, variations, amendments
- Coordinate with cross-functional teams, including R&D, Quality Assurance, Quality Control, Manufacturing, Production, Validation, Engineering, Packaging Development
- Prepare and review product labels, carton artwork, package inserts, prescribing information, and other labeling documents to ensure regulatory compliance
What you need
- Regulatory affairs
- GMP
- Documentation
- Quality control