Regulatory Affairs CMC Manager - Beijing
Amgen
- Beijing
- Permanent
- Full-time
- To facilitate cross functional (with Global Reg-CMC, China RA TA & operation teams, China Supply Chain, China QA etc.) matters
- To facilitate QC testing (pre-load) for MAA or post-approval variation, including but not limited to QC sample/RS/reagent preparation, initiating the QC testing process in China local lab and follow up.
- Prepare CMC components in MAA dossiers for Amgen products in collaboration with Global Reg CMC
- Prepare and update CMC document for CTN in collaboration with Global Reg CMC
- Participate in Project Teams and PST as a Local CMC expert.
- Interact with Chinese Health Authorities on CMC related topics.
- Provide CMC information for investigational products and medical devices used in clinical trials in China.
- Responsible for LCM for post approval products for variations in strategy, executions, and provide advice to global on the global Operations variation plan.
- Execute for Registrational Quality Testing application dossier, sample & materials preparation and submission in collaboration with cross-functional teams.
- Lead/Support CMC related HA regulation/guidance doc commenting/training/discussions based on team assignment.
- Lead/Support CMC related internal SOP/GDE/Manual updating/drafting based on team assignment.
- CMC-specific local regulatory knowledge & experiences
- Biologics-specific regulatory knowledge & experiences – preferred
- Communication skills in Chinese and English
- Team player
- English conversation, read, and writing.
- Computers: Microsoft Outlook/ Word/ Excel/ Power Point/ Project
- Over total 8-10 years’ experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting CDE consultation, NIFDC Quality test submissions, and CTN/MAA submission in China
- Master or Doctor degree