仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／生産管理、品質管理、施工管理、EHS、PMS |
|---|---|
| 業種 | 医療／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | その他 |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 |
日本語 （流暢に話せるレベル） 英語 （ビジネスレベル） |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
Company Overview
大手外資製薬メーカー（オンコロジー領域に強み）
Job Description
CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls
• Collaborate with our HQ CMC RA members to appropriately advance the CMC development stage of the project in charge, and prepare CTD CMC parts (i.e. Manufacturing method, Specifications and test methods, and Stability) logically with high scientific quality.
• Identify product issues and assess risks from the CMC viewpoint, and plan countermeasures.
• Provide CMC-RA information obtained from regulatory authorities or industry associations to Japan/overseas relevant divisions, and discuss with them.
• Evaluate CMC related changes and take appropriate RA action, if necessary.
• Appropriately respond to questions from the authorities on consultations or on review for approval, or negotiate if necessary.
• Cooperate with our HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.
Requirements
• Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs.
• Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
• Practical English speaking ability (TOEIC score 730 and over）.
• Practical skills in E-mails, Word, Excel, Power Point, Acrobat.
• High level of compliance awareness.
• A person cooperative, voluntary motivated, and patiently challenge the issues toward solution.
Desired Qualifications
• Experience of commutation with overseas
面接について
連絡先
CMC Scientist (Chemical)
RGFタレントソリューションズ株式会社
450 〜 830 万円
