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