Job Resonsibilities:
1. Managed regulatory submissions for product approvals in international markets, ensuring timely clearances.
2. Verified product labels for accurate claims, ingredient lists, and compliance with regulatory standards.
3. Coordinated with regulatory authorities to resolve queries and expedite product registrations.
4. Assisted in the preparation and management of Quality Control Documentation, ensuring compliance with GMP and regulatory guidelines.
5. Gained hands-on experience in compiling regulatory dossiers, including CMC (Chemistry, Manufacturing, and Controls) sections.
6. Reviewed and organized documents related to batch records, deviations, and change control.
7.
Manage the preparation of full ACTD dossiers, compiling all required documents according to the ASEAN Common Technical Dossier format. Ensure each section meets regional requirements, including quality, safety, efficacy, and manufacturing information.
8. Maintain regulatory databases, track submissions, and ensure proper documentation