- Prepare and compile regulatory dossiers (CTD/ACTD format) for product registrations in international markets.
- Coordinate with manufacturers to obtain regulatory documents such as COA, GMP, Stability Data, FSC/CPP, and product permissions.
- Manage product registration submissions, renewals, and variations with regulatory authorities.
- Respond to regulatory queries and deficiencies from importing country authorities.
- Review and approve product artworks, labels, and packaging to ensure regulatory compliance.
- Maintain and update regulatory documentation database and submission tracking.
- Support the Business Development team by providing regulatory documents required for product registration and market entry.
- Assist BD team in product selection and documentation for current market opportunities.
- Coordinate with international distributors for regulatory requirements and product approvals.
- Work closely with QA, manufacturing partners, and logistics teams to ensure compliance and timely supply.
- Provide technical and regulatory information required for tenders, quotations, and client discussions.