職位描述
Responsibility:
1. Manages, prepares and submits regulatory applications in China & Hong Kong
2. Manages, prepares and submits responses to questions within specified timelines.
3. Undertakes interactions and negotiations with Regulatory Authorities to secure and optimise
regulatory approvals concordant with strategic company goals.
4. Plans and prioritises maintenance activities and regulatory variations to ensure products
comply with conditions of registration, China and Hong Kong regulatory requirements.
5. Prepares product information (PI), consumer medicine information (CMI) documents and
Data Sheets.
6. Reviews labelling and packaging, promotional and educational material in line with
regulatory requirements and China and Hong Kong Codes of Conduct.
7. Interacts with personnel from overseas offices and HQ to achieve strategic company goals
and provide advice on China & Hong Kong requirements.
8. Participates in project planning and regulatory strategic plans in cooperation with local
company personnel and HQ staff to achieve and optimise strategic company goals.
9. Keeps the Medical Director and Regional General Manager advised of the progress of
regulatory projects, identifying and discussing sensitive or critical issues and potential
solutions before implementation.
10. Interacts with and manage the activities of contractor or consultants in the preparation of
regulatory submissions
11. Keeps up-to-date with government legislation relating to regulatory affairs in China & Hong
Kong
12. Provides advice regarding regulatory matters to other local company personnel.
13. Contributes to company systems development, maintain regulatory document management
systems.
14. Carries out any other relevant activities as prescribed by the Medical Director.
15. Assists in the review of regulatory aspects of Promotional Materials to ensure compliance
Requirement:
1. University degree in pharmacy, science, biomedical/life science. Higher degree desirable;
2.5-7 years regulatory affairs experience in the preｓcription pharmaceutical area. Experience with OTC products
desirable.
3. Experience with new chemical entities (NCE) and/or biopharmaceutical applications, knowledge and
understanding of drug development processes. Preferably with a multinational pharmaceutical company.
4.Experience with China & Hong Kong regulatory affairs processes.
