Job Summary

Responsible for managing regulatory affairs activities for Finished Dosage Formulations (FDF) manufactured through third-party/contract manufacturing partners and marketed under the company's own brands in international markets. The role involves dossier compilation, product registrations, lifecycle management, coordination with manufacturers and regulatory authorities, and ensuring compliance with country-specific regulatory requirements to support business growth across export markets.

Key Responsibilities:

Regulatory Submissions & Product Registrations

· Prepare, review, compile, and submit registration dossiers for products manufactured by third-party manufacturers and exported under the company's brand.

· Manage recent registrations, renewals, variations, amendments, and re-registrations across international markets.

· Coordinate responses to regulatory queries and deficiency letters within stipulated timelines.

· Maintain registration trackers and ensure timely approvals to support market launches.

Third-Party Manufacturer Coordination





· Liaise with contract manufacturers to obtain regulatory documents, technical data, stability studies, specifications, validation documents, GMP certificates, and other supporting information.

· Review manufacturer documentation to ensure compliance with importing country requirements.

· Coordinate change control activities and assess regulatory impact arising from manufacturing, formulation, packaging, or site changes.

Regulatory Compliance & Documentation

· Ensure dossiers and supporting documents comply with WHO, ICH, and country-specific regulatory requirements.

· Maintain and update regulatory databases, product dossiers, licenses, approvals, and registration records.

· Monitor registration validity and initiate renewals proactively.

Cross-Functional & Business Support

· Work closely with International Business, Sourcing, QA, Supply Chain, and Packaging teams to ensure timely product registrations

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