メディカル・バイオ - 薬事申請

The Regulatory Affairs Senior Manager is responsible for leading regulatory activities from development through life cycle management in collaboration with global and Japan stakeholders. Key responsibilities include managing interactions with health authorities, leading NDA and sNDA submissions, preparing Japan-specific regulatory documents, overseeing post-marketing change control processes, and managing electronic package inserts and promotional material reviews. The role also involves mentoring team members, managing vendors, supporting SOP updates, and ensuring compliance with regulations while driving process improvements.

■休日：完全週休二日制

・Experiences and knowledge in Regulatory Affairs, especially development or post-marketing activity.
・Experiences of Collaborating with cross-functional team and global member.
・Language: Japanese- native level. English: Able to communicate with global members as J-RA representative.
・Stakeholder management, Communication/coordination, leadership/ownership skills, strategic consideration and project/risk management skills.

■職種未経験者：不可