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About the Role
The 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.
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.
Work Type
- Hybrid
Experience Level
- Manager
Benefits
- 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.
About the Company
- 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.
- AbbVie is an equal opportunity employer and is committed to the principles of integrity, innovation, improving lives, and contributing to the community. We actively support individuals with disabilities in our equal employment opportunities.
Equal Opportunity
- 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.
- AbbVie is an equal opportunity employer and is committed to the principles of integrity, innovation, improving lives, and contributing to the community. We actively support individuals with disabilities in our equal employment opportunities.