Offer summary

Qualifications:

Over 10 years of experience in regulatory CMC or CMC operations in the pharmaceutical industry, particularly with biologics., Master's or Doctorate degree in a related field., Strong knowledge of local regulatory requirements for CMC, including biologics and chemical products., Proficient communication skills in both Japanese and English..

Key responsibilities:

Prepare and submit NDA/CTD/PCA/MCN consultation dossiers in collaboration with global teams.

Provide CMC information for investigational products used in clinical trials to local development operations and external vendors.

Interact with Japanese Health Authorities and facilitate cross-functional matters with various regulatory teams.

Participate as a local CMC expert in project teams and provide updates on CMC documentation.

Job description

Career Category

Regulatory

Job Description

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

Requirements:

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
Master or Doctor degree in related area
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

Required profile