CMC,RA

Company Overview
【糖尿病領域シェアNo.1】定着率◎/ヨーロッパ系製薬メーカー

Job Description
The Regulatory CMC Expert is responsible for approval and maintenance of marketing authorization of pharmaceuticals through close communication between the company and the local Regulatory Authorities and generation of high quality documents aligned with the local regulatory/CMC requirements and company standards. This position supports and collaborates with the Group Manager and other members in not only Regulatory CMC Group but also SDRA and Development Division to maintain an excellent working environment as One Team.

Major Tasks & Accountabilities:
1) Prepare Japanese CTD modules 2.3 and 3, application sheet, responses to questions from PMDA/MHLW and other documents for submission, with high quality, in cooperation with the global HQ.
2) Review/QC CMC-related NDA documents and responses to questions from local Health Authorities.
3) Discuss and contribute to develop regulatory and submission strategies based on science and local CMC-related requirements with global HQ for new products and life cycle products.
4) Interact effectively with local Regulatory Authorities and/or external experts and give the feedback to Group members and internal stakeholder including global HQ.
5) Provide CMC and regulatory expertise to SDRA, other Department and Division staff.
6) Collaborate with and coach, if necessary, Group members to accomplish Group Goals and to develop members’ skill and competency.

Requirements
Experiences / 経験:
製薬会社でのCMC薬事関連業務（10年以上）
バイオ医薬品の承認および一変申請書作成、当局対応、および承認取得

Knowledge / 知識:
CMC関連規制、分子（応用）生物学

Qualifications / 資格:
薬学、理学あるいは農学修士

Education / 学歴:
修士課程修了あるいは相当する学歴

Language / 言語能力:
Native Japanese with English fluency (TOEIC 700+)

PC Skills / PCスキル:
Outlook, Words, Excel, PowerPoint

Competency / コンピテンシー:
1) 承認申請（バイオ医薬品のCMC関連CTD作成及び規制当局からの照会事項対応）
2) 英語でのコミュニケーション（海外関連部門からの情報収集及び交渉）
3) チームワーク


必須ではないがあると望ましい要件:
薬学、理学、あるいは工学博士
薬剤師免許

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