Regulatory Affairs Sr. Managerの転職・求人情報 30813707

募集要項

仕事内容: To leverage your expertise in regulations governing drug development to advance our portfolio.
－ Act as the liaison between the company and the PMDA and other health authorities for assigned programs.
－ Develop regulatory strategies in collaboration with senior management, including analysis of guidance and assessment of oncology/hematology drug development. Aim to secure approval for activities that support our development and marketing objectives.
－ Manage regulatory activities associated with development programs and participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
－ Mentor multidisciplinary teams on the content, format, style, and structure of Japan submissions. Plan and implement Japan regulatory strategies, including PMDA consultations for assigned projects in the oncology/hematology portfolio with global regulatory teams.
－ Ensure timely submissions of marketing applications and post approval changes for assigned projects.
etc.

応募資格

必須: － Extensive knowledge of global and Japanese regulations governing drug development.
－ Experience in regulatory affairs
－ Strong analytical skills and the ability to interpret and manage clinical, preclinical, and manufacturing data.
－ Excellent written and verbal communication skills.
－ Proven ability to mentor and guide multidisciplinary teams.
－ Strong organizational and project management skills.
－ Familiarity with PMDA guidelines and international regulatory requirements.

フィットする人物像: こんな方なら向いている
―　外資バイオベンチャーが初日本市場参入したフェーズにおいてグローバルカウンターパートと近い距離で日本薬事部門の立ち上げ経験を積みたい人
ー　日本オフィスの初製品導入申請に携わりたい方
ー　意思決定のスピード感が速く、革新的な技術をもっている企業
ー　柔軟的な働き方をしながら申請業務に携わりたい方（ハイブリッド勤務＋スーパーフレックスタイム制、コアタイムなし）