Registration Manager

Position: Registration Manager

Responsibilities

1. Oversee the registration of company products in Singapore and the Southeast Asia region.

2. Possess a comprehensive understanding of the end-to-end development process for innovative drugs (chemical and/or biological) and generics (chemical and biological) as well as medical devices. Identify and address potential risks specific to the registration phases in Southeast Asian countries, and advance projects in line with company objectives.

3. Coordinate with internal departments, external partners, and other relevant organizations for overall project planning and management. Collect, organize, and submit required documentation for product registration according to the regulatory requirements of Southeast Asian authorities.

4. Track the review of registration documents, respond promptly to any queries or issues arising during the review process, and maintain effective communication with regulatory bodies and partners.

5. Assist in preparing and executing on-site GMP audits per the requirements of regulatory agencies in Southeast Asia.

Requirements

6. Master's degree or higher in Biology, Pharmacy, Clinical Medicine, or a related field.

7. Singaporean citizenship or permanent residency.

8. At least three years of experience with product registration in Southeast Asian countries, with a preference for candidates who have successfully registered products independently.

9. Familiarity with pharmaceutical registration regulations and submission processes in Southeast Asian countries.

10. Strong communication skills (both oral and written) and fluency in Chinese as you will be dealing with Clients based in China and Taiwan.

11. Excellent learning, communication, and project management abilities, with a strong aptitude for handling and resolving issues in the registration process.