募集要項
- 仕事内容
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こんな方なら向いている
― 開発段階から承認取得後まで全段階においての薬事戦略業務を幅広く担当したい方
ー 抗体治療、免疫療法、および小分子治療薬の分野で多くの新薬候補を開発しており、がん治療薬の研究開発において強力なパイプラインを持っている外資ベンチャーで働きたい方
ー 意思決定にスピード感があり、専門性の高いチーム環境の中で自主性をもって業務推進したい方
ー 柔軟的な働き方をしながら業務に携わりたい方（フルリモート可能）
This RA Associate Director will play a pivotal role in shaping and executing regulatory strategies to secure and maintain market access for our innovative products in Japan. This position involves managing all regulatory aspects of compounds and biologics throughout their lifecycle, from development through post approval. The successful candidate will provide strategic regulatory oversight, ensuring compliance with the latest requirements and standards. Externally, this individual will interface with regulatory agencies and business partners regarding development, regulatory, and registration strategies. Additionally, this role includes line management, people development, performance management, and supporting the development and implementation of departmental policies.
- 応募資格
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- 必須
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－ Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in a regulatory capacity.
－ Minimum of 5 years of experience working on development programs in Japan as a regulatory lead, with experience in both small molecules and biologics.
－ Thorough understanding of the drug development process, the pharmaceutical industry, and the healthcare environment, including regulatory requirements and policy trends.
－ Extensive regulatory experience with CTNs, NDAs/BLAs/MAAs, lifecycle management, interactions with Japan Health Authorities, leading and managing regulatory teams, and developing and implementing regulatory strategies with a proven track record of accomplishments.
- 募集年齢(年齢制限理由)
- 定年退職年齢の上限の為 （定年年齢を上限として募集するため）
- 雇用形態
- 正社員
- 勤務地
- 茨城県 / 栃木県 / 群馬県 / 埼玉県 / 千葉県 / 東京都 / 神奈川県 / 山梨県
- 年収・給与
- 要相談
- 選考プロセス
- 書類選考＋面接複数回
