Proficiency in written and spoken chinese and english
The role involves leading regulatory affairs activities for the Taiwan Rare Disease portfolio under the supervision of the Head of Affiliate Regulatory Affairs
Job Summary
The role involves leading regulatory affairs activities for the Taiwan Rare Disease portfolio under the supervision of the Head of Affiliate Regulatory Affairs.
Candidates must ensure timely filing of new product registrations, renewals, and updates to maintain compliance with local regulations.
Sanofi offers a supportive team environment with opportunities for career growth through promotions or lateral moves at home or internationally.
Matching Summary
The role involves leading regulatory affairs activities for the Taiwan Rare Disease portfolio under the supervision of the Head of Affiliate Regulatory Affairs.
Skills & Requirements
Must-have
5-8 years regulatory affairs experience
NDA and plant registration project completion
Proficiency in written and spoken Chinese and English
Nice-to-have
Experience with ODD and ODA submissions
Knowledge of TFDA and CDE regulations
Ability to propose solutions to complex problems
Key Requirements
Scientific background in Pharmacy preferred
Minimum 5-8 years experience in regulatory affairs
Experience completing NDA and plant registration projects