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| 部署・役職名 | 【立ち上げ・外資バイオベンチャー】RA Sr. Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
こんな方なら向いている ― グローバル基盤がしかっりした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 日本オフィス開発薬事部門の一人目として日本へ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） Summary: We are seeking a knowledgeable and experienced Regulatory Affairs Specialist to join our team. This role involves leveraging your expertise in global and Japanese regulations governing drug development to advance our portfolio. Your responsibilities will encompass preclinical and clinical drug development programs, policies, and procedures. This is a unique opportunity to lead regulatory processes for oncology/hematology products in Japan and establish our profile with key local collaborators. Job Responsibilities: － 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. － Perform and manage critical analyses of data （clinical, preclinical, and manufacturing）. Develop interpretations and conclusions independently. Review clinical protocols and study reports to identify and address deficient or missing items/explanations. － Ensure the completeness and accuracy of all regulatory submissions. Supervise the planning, preparation, and submission of regulatory documentation: － Provide guidance to multidisciplinary teams on the content, format, style, structure, and timing of regulatory submissions （biologics）. － Assist with the scientific writing and review of a BLA and evaluate conformance with regulatory requirements. － Monitor newly published PMDA guidelines and international guidance documents relevant to new and ongoing development programs. Provide training on applicable requirements for scientific staff as needed. |
| 応募資格 |
【必須（MUST）】 － Extensive knowledge of global and Japanese regulations governing drug development.－ Experience in regulatory affairs, particularly in oncology/hematology. － 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. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/11/21 |
| 求人番号 | 4054278 |
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