Regulatory Affairs Executive / Senior Executive - LVP

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
• Any graduate