Summary of Job Description:

Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes.

Major Responsibilities:

• Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW.
• Collaborate with cross-functional project teams (e.g., Clinical Development, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
• Lead and implement regulatory strategies, considering both global and local requirements.
• Interact with PMDA/MHLW and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
• Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
• Support the development and maintenance of regulatory SOPs and best practices, if applicable.
• Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.

Qualifications

Summary of Job Description:

Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes.

Major Responsibilities:

• Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW.
• Collaborate with cross-functional project teams (e.g., Clinical Development, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
• Lead and implement regulatory strategies, considering both global and local requirements.
• Interact with PMDA/MHLW and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
• Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
• Support the development and maintenance of regulatory SOPs and best practices, if applicable.
• Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.

Additional information

What you can expect

• Individual development opportunities and chance to utilise our internal learning platform with a range of learning paths to choose from.
• The opportunity to be part of a collaborative global working environment with support from passionate colleagues around the globe

Internal Mobility at Korn Ferry

If you currently work for Korn Ferry or one of our affiliates, you must be eligible to apply for a different position within Korn Ferry to use the Careers Site. If you accept such a position, your benefits programs and Human Resources policies may change. Please consult with your HR contact for the new position concerning application eligibility, including any immigration/visa needs, benefit programs, and HR policies applicable to that position.

Korn Ferry is an Equal Employment Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。