CMCマネージャー

Job Details

Job Summary

The CMC Manager will deliver regulatory / CMC documents for Japan market approvals to the submission team and work closely with global members / manufacturing sites for CMC, Quality and Regulatory matters.

 

Responsibilities

• J-NDA, PCA and MCN including CTD preparation / response to PMDA inquiries
• PMDA consultation
• DMF (drug master filing)
• FMA (foreign manufacture accreditation) application
• Analysis, evaluation of global overseas CMC data
• GMP (good manufacturing practice) compliance review / inspection

 

Qualifications

• At least 3 years of regulatory / CMC experience, supported by additional pharmaceutical / industry experience
• Leadership skill to manage the activities of the Japan Region in line with the Global Regulatory Affairs activities
• Experience dealing with CMO’s is preferred
• Experience communicating with global counterparts

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company