Regulatory Assistant Manager
Consultant Rica Chuang
Date posted 29 November 20192019-12-03 2020-01-28 pharmaceuticals Taipei TW TWD 1200000 1400000 1400000 YEAR Robert Walters https://www.robertwalters.com.tw https://www.robertwalters.com.tw/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
A Global Pharmaceutical Company look for a Regulatory assistant manager to contribute to the company’s regulatory affairs matter. The responsibilities include NDA and new indication application, license expansion.
- The official consultation case of related laws and regulations on the submission of new drugs, providing a more appropriate solution for the research and development of the company's products to facilitate the early listing
- New drug inspection registration and new indication application
- Application for registration and follow-up inspection of pharmaceutical factories and operation items related to drug inspection and registration
- Post-marketing drug license management and related change applications
- Introduction to new product related knowledge and corresponding pharmaceutical regulation
- Bachelor degree or above in pharmacy or related fields is preferred. Major in pharmacy is a plus.
- More than three year experience in regulatory affairs in multinational company is preferred.
- Biological product registration and overseas PMF on-site inspection experience is a plus
- Fluent in English Communication
- Good interpersonal/communication skills, ability to interact effectively in a team environment within the functional team and with all cross functions
- Team work spirit and strategic thinking
About the organisation
Our client is one of the pharmaceutical groups in the world to master various advanced in Ethical/ Prescription Drug.
Also our client is a well-known and well respected pharmaceutical company. Through the outstanding knowledge and commitment of our 10,000 employees worldwide, they create innovative new and generic medicines, and new methods of drug discovery and delivery.