Regulatory Affairs CMC Manager

1 month ago

Beijing, China Amgen Full time

Job Summary

Regulatory CMC China Manager is responsible for execution of the China -specific product strategies align with the global strategy. This position prepares CMC relevant documents and submits CTNs / MAAs dossiers in collaboration with Global Reg CMC and Operations and may need support from the local Managers partially. This position provides CMC information of investigational products used in clinical trials to local Dev Ops and external vendors.

Regulatory CMC China Manager/ is also responsible for the following.

  • 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.

Key Activities

  • 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.

Knowledge and Skills

  • 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

Education & Experience (Basic)

  • 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

Education & Experience (Preferred)

  • Master or Doctor degree

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