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
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コントラクトMR【年齢・領域経験不問】
大手外資系CSO日本全国- 掲載中 2021-01-15
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製薬業界でのキャリア
製薬企業東京、関西- 年収 6,000,000 - 25,000,000 円/年
- 掲載中 2021-01-12
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エリアマネージャー
グローバル製薬企業仙台、大宮- 年収 -14,000,000 円/年
- 掲載中 2021-01-06
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アカウンティングマネージャー/アソシエイト
大手外資系製薬企業東京- 掲載中 2020-12-21
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ブレストインプラントMR
グローバルヘルスケアカンパニー東京- 年収 7,000,000~10,000,000 円/年
- 掲載中 2020-12-21