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| 部署・役職名 | 【フルリモート可能・オンコロジー特化・外資バイオベンチャー】RA Associate Director |
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| 仕事内容 |
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） General Description: The Associate Director, Regulatory Affairs, Japan 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. Responsibilities Essential Functions: － Provide high－level strategic and operational regulatory direction and mentorship on projects, including general regulatory strategies, clinical study requirements, marketing approval in Japan, strategic development plans, risk assessments, critical issue management, and advice on Health Authority interactions. － Leverage extensive knowledge of Japan and ICH regulatory requirements to support development projects and marketed product regulatory issues, aligning with corporate goals. － Prepare and submit documentation to support investigational and marketing registration packages in Japan, ensuring compliance and timely submissions. － Review CTN, NDA, and other submission documents for clinical trials and marketing applications, and their amendments, in compliance with Japan regulatory requirements. － Liaise and negotiate with Japan regulatory authorities on all aspects of drug development, including resolving key regulatory issues and expediting product and labeling change approvals. － Maintain awareness of Japan and global regulatory environments and assess the impact of changes on business and product development programs. Facilitate policy development and standard interpretation of Japan regulations. － Integrate functional expertise with business knowledge to solve problems and make sound decisions for the overall business. － Train, develop, and manage direct reports. － Manage critical issues, leading the regulatory contribution. － Assist with the development and implementation of regulatory processes. Recruit, develop, manage, and mentor regulatory professionals, fostering a goal－oriented culture. |
| 応募資格 |
【必須（MUST）】 Core Competencies, Knowledge, and Skill Requirements:－ 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. － Strong strategic skills, including creativity and effectiveness in addressing major strategic challenges and the ability to balance short－term needs with long－term vision. － Proven ability to achieve goals within a cross－functional team/partnership environment with a high level of professionalism. － Strong PC literacy; proficiency in MS Office （Outlook, Word, Excel, PowerPoint）. － Ability to work on a computer for extended periods. Communication ＆ Interpersonal Skills: － Excellent interpersonal, oral, and written communication skills in Japanese and English, with the ability to produce high－quality, grammatically accurate regulatory documentation in Japanese. Capable of analyzing, defining, and effectively conveying complex issues to internal and external stakeholders. － Skilled in conflict resolution and negotiation, fostering open communication, listening, and facilitating discussion. － Strong negotiating skills and the ability to think creatively and develop innovative solutions. － Proven ability to build trust and respect within the organization. Ability to prioritize and manage multiple projects simultaneously. － Interacts with company employees and senior management. Interacts with external business partners and regulatory agencies. |
| 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 | 2024/11/06 |
| 求人番号 | 4011835 |
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