Job Profile: International Regulatory Affairs
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 prospects.
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.