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 maintenance of marketing authorizations in compliance with local regulations.
Sanofi offers a supportive, future-focused team environment with opportunities for career growth and a rewards package that recognizes contributions.
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
Proficiency in written and spoken Chinese
Proficiency in written and spoken English
Experience with NDA and plant registration
Knowledge of local regulatory regulations
Nice-to-have
Experience with ODD and ODA projects
Work experience in TFDA and/or CDE
High team spirit with integrity
Ability to handle pressure and deadlines
Strong negotiation skills
Key Requirements
Scientific background in Pharmacy preferred
Minimum 5-8 years experience in regulatory affairs
Essential proficiency in Chinese and English languages