Regulatory Affairs Officer

1. Prepare, review, and submit documents for new product registration, registration renewals, and amendments or changes to registrations after approval.
2. Coordinate with the Food and Drug Administration (FDA), manufacturers, and product owners regarding product registration and regulatory requirements.
3. Monitor registration status and regulatory deadlines, including preparing clarifications and submitting additional information as requested by regulatory authorities.
4. Oversee and monitor the regulatory status of registered products, including post-registration changes and Regulatory Lifecycle Management.
5. Support the Business Development team in assessing regulatory feasibility for new products.
6. Review product information, labels, package inserts, packaging materials, and promotional materials or product-related media to ensure compliance with relevant regulatory requirements.
7. Prepare, control, oversee, and maintain complete, accurate, and up-to-date regulatory documents and registration submission dossiers.
8. Coordinate with relevant internal departments such as Sales, Marketing, Quality Assurance, and Business Development.
9. Monitor laws, regulations, and regulatory requirements related to the company's products, including assessing the impact of regulatory changes.
10. Prepare registration status reports and relevant regulatory reports for presentation to management.
11. Perform other duties as assigned by supervisors.

Qualifications:

1. Age 25 years or older.
2. Bachelor's degree in Pharmacy, Science, Medical Science, or other related fields.
3. At least 1–2 years of experience in Regulatory Affairs or registration of pharmaceutical/health products.
4. Knowledge of FDA laws, regulations, and requirements related to pharmaceutical products.
5. High attention to detail in preparing, reviewing, and managing various registration documents.
6. Ability to follow up and coordinate accurately with the FDA, manufacturers, product owners, and relevant agencies.
7. Good reading and writing skills in English, especially for reading academic and Regulatory Affairs documents.