Regulatory Affairs Associate Directorの転職・求人情報 30512765

募集要項

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）

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

必須: － 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.

事業内容・会社の特長: A renowned global, science driven biotechnology company listed on multiple stock exchanges, dedicated to developing groundbreaking and affordable medicines to revolutionize treatment outcomes and access for patients worldwide. With a broad portfolio of over 40 clinical trial candidates, the company is committed to fast-tracking the development of our diverse pipeline through strategic collaborations and our own internal capabilities.