CMC development director with BH-175139

A biotech company in China is currently hiring for a CMC development director:

Key job responsibility

Formulate drug preparation R&D strategies according to relevant requirements and guiding principles, and organize CMC related contents;
Communicate with FDA/NMPA and relevant agencies in time for relevant opinions and suggestions in the pre-clinical development stage;
Be responsible for the supervision and management of contract negotiation, process supervision, project quality, project progress and achievement handover of CRO outsourcing projects related to CMC.

Job requirement

Doctor degree, major in pharmacy, pharmaceutics and other related majors, with more than 5 years of preparation development experience;
Familiar with drug development policies and relevant technical requirements and familiar with the new drug application process and the writing of application materials;
Solid theoretical knowledge and operational skills of pharmaceutical preparations, and be familiar with common pharmaceutical equipment;
Good Chinese and English expression and writing skills.

CMC development director