Regulatory Affairs Executive / Senior Executive - LVP
Posted Updated
Description
- 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.
- Handle regulatory submissions and Hands-on experience through the CDSCO and State DCA online portals, and manage all regulatory correspondence to ensure timely submission, effective follow-up, and receipt of required approvals and Experience in CTD/eCTD/ACTD dossier preparation and lifecycle management.
- 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.
- Coordinate with cross-functional teams, including R&D, Quality Assurance, Quality Control, Manufacturing, Production, Validation, Engineering, Packaging Development, and Supply Chain, to obtain and maintain documentation required for regulatory submissions.
- Prepare and review product labels, carton artwork, package inserts, prescribing information, and other labeling documents to ensure regulatory compliance.
- Support new product registrations and product lifecycle management activities for domestic and export markets.
- Prepare responses to regulatory deficiency letters, agency queries, and requests for additional information.
- Ensure compliance with applicable regulatory guidelines, GMP requirements, and company quality systems.
- Review regulatory changes and assess their impact on existing products and ongoing regulatory submissions.
- Maintain regulatory databases, submission trackers, approvals, licenses, and product registrations.
- Support regulatory inspections, GMP audits, and customer audits by providing required regulatory documentation.
- Participate in change control evaluations and assess regulatory impact for manufacturing, formulation, packaging, and process changes.
- Coordinate with international distributors, business partners, and regulatory consultants for export registrations and regulatory compliance.
- Ensure timely renewal of manufacturing licenses, product registrations, Free Sale Certificates, COPP, and other regulatory approvals as applicable.