Manager of Regulatory Affairs & Public Policy at Rowan Digital Infrastructure shaping communications and strategies. Leading advocacy in the evolving regulatory landscape for data centers.
About the role
- Lead Japan CMC & Devices RA New Drug Application group at Takeda, overseeing regulatory strategies and team development for drug approvals. Drive communication with health authorities and stakeholder management.
Responsibilities
- 日本における医薬品(化学合成品、バイオ医薬品)の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者
- 申請戦略・申請計画のCMCパートについて立案・遂行
- 薬事関連の当局相談に係る戦略策定及び遂行
- 製造販売承認申請業務(CMCパート)
- 導入案件のCMC薬事関連の評価
- グループメンバーの教育訓練及び人財育成
Requirements
- 4年制大学(理系学部)卒業以上(修士以上であることが望ましい)
- 以下の業務の知識経験が10年程度以上
- 化学合成品、バイオ医薬品及びコンビネーション医薬品の医薬品の研究開発、製造、試験に関わる知識経験
- 医薬品開発及び承認申請業務及び市販後の変更管理に基づく薬事手続きの知識経験
- 日本の規制当局との面談及び相談の実務経験
- 国内外のステークホルダーとの良好な関係構築及びコミュニケーション
- 組織運営/人材マネジメントの実務経験(5年以上の経験を持つことが望ましい)
- 医療用医薬品に関する規制要件・ガイダンス(ICH、薬機法、欧米の要件、等)に関する知識
- GMP(治験薬含む)に関わる業務経験を有することが望ましい
- ビジネスレベルの十分な日本語及び英語でのコミュニケーション能力(TOEIC 750点以上等)
Benefits
- Commutation, Housing, Overtime Work etc.
- Salary Increase: Annually, Bonus Payment: Twice a year
- Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
- Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
- Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
- Flexible Work Styles: Flextime, Telework
- Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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