Regulatory Affairs Specialist

1. Responsible to ensure product registration compliance by keeping current with health authorities’ requirements and regulations pertaining to Taiwan.
2. Plan, manage and prepare regulatory submission in compliance with corporate standards and regulatory requirements.
3. Develop and implement regulatory strategies to achieve rapid and high quality approvals and facilitate rapid launch for new products.
4. Ensure successful and timely product registration ( ANDA ＆ DMF)).
5. Ensure timely NHI price application.
6. Ensure maintenance of existing product licenses.
7. PMF/GMP application and maintenance.
8. Support GDP and PV maintenance.
9. Provide cross-functional support.
10. Other assignments.

職缺特色