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About the Role
Manager II, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities for projects with high complexity and strategic impact, acting as a senior core member and regulatory lead within project teams. This role drives robust regulatory strategies across the product lifecycle, ensures timely and high-quality regulatory deliverables, and maintains full compliance with applicable regulations and company policies. In addition to project execution, the Manager II supports and develops RA team members, provides technical and strategic guidance, and contributes to team management within and across therapeutic areas, strengthening overall regulatory capability and operational excellence.
Responsibilities
- Lead regulatory affairs activities for complex or high-impact projects across assigned therapeutic areas, including preparation, review, and oversight of regulatory submissions (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW.
- Serve as a regulatory lead and key strategic partner within cross-functional project teams (e.g., Clinical Development, Project Management, Commercial), providing proactive and solution-oriented regulatory input throughout product life-cycle management.
- Develop, optimize, and implement regulatory strategies that address complex regulatory challenges while ensuring alignment between global and Japan-specific requirements.
- Act as a senior point of contact for interactions with PMDA/MHLW, leading regulatory communications, facilitating issue resolution, and guiding teams through complex regulatory discussions.
- Identify, assess, and manage regulatory risks, including scenario planning and development of contingency strategies for complex programs.
- Coach, support, and train RA team members, sharing expertise, reviewing key deliverables, and contributing to talent development and capability building within and across TAs.
- Contribute to team management and cross-TA collaboration, including knowledge sharing, process improvement initiatives, and alignment of regulatory practices.
- Lead or significantly contribute to departmental and cross-functional initiatives to enhance regulatory processes, operational efficiency, and regulatory excellence, if applicable.
Requirements
- Strong and practical knowledge of Japan’s regulatory requirements, procedures, and PMDA/MHLW expectations, with the ability to manage complex regulatory issues.
- Proficiency in planning, executing, and monitoring projects to ensure delivery within scope and timelines.
- Strong analytical skills with a proactive, risk-based approach to resolving complex regulatory and operational challenges.
- Ability to mentor and support team members, foster knowledge sharing, and positively influence team performance.
- Excellent verbal and written communication skills in Japanese and business level in English, with the ability to influence cross-functional and global stakeholders.
- Exceptional attention to detail with a robust understanding of regulatory frameworks and industry requirements.
- Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering).
- Substantial experience in regulatory affairs within the pharmaceutical or healthcare industry, including hands-on leadership of regulatory submissions and PMDA interactions.
- Extensive project experience in new drug development and life-cycle management, with demonstrated ability to manage complex or high-risk programs.
- Experience guiding or mentoring junior team members and contributing to team or functional leadership is strongly preferred.
Skills
- Regulatory Affairs
- Project Management
- Problem-Solving
- Leadership
- People Development
- Communication (Japanese and English)
- Compliance
Experience Level
- Manager II
- Workday Global Grade: 17
Education Level
- Bachelor’s degree
- Master’s degree
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to the honest and responsible conduct of business, driving innovation, and making a remarkable impact on people's lives and communities.
- We actively support individuals with disabilities in their pursuit of employment opportunities.