Regulatory Affairs

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 new 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.