CMC manager

amgen· 1112 Amgen K.K.
Apply Now ↗
📍 Japan - TokyoFull time

About this role

Career Category

Regulatory

Job Description

Group Purpose

To facilitate product development by developing and executing the regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Job Summary

Regulatory CMC Japan Manager is responsible for execution of the Japan-specific product strategies align with the global strategy.  This position prepares and submits NDA/CTD/PCA/MCN/consultation dossiers in collaboration with Global Reg CMC and Operations, and may need support from the local Senior Manager partially. This position provides CMC information of investigational products used in clinical trials to local Dev Ops and external vendors.

Key Activities

  • Prepare CMC components in NDA/CTD/PCA/MCN/consultation dossiers for Amgen products in collaboration with the Senior Manager, Regional and Global Reg CMC
  • Prepare and update CMC document for CTN in collaboration with Regional and Global Reg CMC
  • Participate in Project Teams and PST as an Local CMC expert
  • Interact with Japanese Health Authorities

Provide CMC information for investigational products and medical devices used in clinical trials in Japan

To facilitate cross functional (with JAPAC RA-CMC, Japan RA, Japan QA etc) matters

Knowledge and Skills

  • CMC-specific local regulatory knowledge & experience
  • Biologics-specific regulatory knowledge & experiences
  • Chemical products specific regulatory knowledge & experiences
  • Communication skills in Japanese and English
  • Team player
  • English conversation, read, and writing
  • Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project

Education & Experience (Basic)

Over total 10 years experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting PMDA consultation, CTN and NDA submission in Japan

Education & Experience (Preferred)

Master or Doctor degree

.

Frequently Asked Questions

Is the salary disclosed for the CMC manager position at amgen?
The salary for this CMC manager role at amgen is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the CMC manager position at amgen located?
This CMC manager role at amgen is based in Japan - Tokyo. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the CMC manager role at amgen full-time or part-time?
This is listed as a Full time position. It is posted as a CMC manager role in the 1112 Amgen K.K. department at amgen.
Which team or department does the CMC manager at amgen belong to?
This CMC manager position is part of the 1112 Amgen K.K. department at amgen. See the full job description for more information about the team structure and responsibilities.
How do I apply for the CMC manager position at amgen?
Click the "Apply Now" button on this page. You will be redirected to amgen's official application portal hosted on workday where you can submit your application directly.
When was the CMC manager job at amgen posted?
This CMC manager position at amgen was posted on Sep 7, 2026. Apply as soon as possible — early applications are often reviewed first.
CMC manager
amgen
Apply for this role ↗

You'll be redirected to amgen's official application page on Workday.