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About the Role
The Senior Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, leads a team of RA TA professionals. This role ensures effective workflow, optimal productivity, professional development, and timely delivery of high-quality regulatory outputs. The Senior Manager develops and implements group strategies, provides leadership, mentors staff, drives operational excellence, and manages development projects.
Responsibilities
- Lead and manage the RA TA team by setting clear objectives and performance expectations.
- Oversee recruitment, onboarding, and ongoing training and development for all team members.
- Allocate projects and responsibilities based on regulatory and therapeutic area expertise, monitor progress, support team members, and ensure timely achievement of deliverables.
- Mentor and coach team members to support their professional and career growth.
- Direct involvement in development projects and life-cycle management activities, including Package Insert maintenance.
- Lead and implement local regulatory strategies as appropriate.
- Foster a collaborative and high-performing organizational culture within the RA TA group and with cross-functional teams.
- Liaise with key internal and external stakeholders (e.g., PMDA, MHLW, global teams) for cross-functional initiatives, including regulatory submissions and therapeutic projects.
- Identify, address, and resolve strategic and operational challenges impacting regulatory and therapeutic area activities.
- Contribute to regulatory policy intelligence and actively monitor relevant regulatory changes and developments.
- Ensure compliance with company policies and all applicable health authority regulations.
Requirements
- Demonstrated experience in leading, motivating, and developing diverse and cross-functional teams.
- Strong ability to prioritize tasks, coordinate multiple projects, and maintain high standards of quality and accuracy.
- Excellent verbal and written communication skills in Japanese and business level in English, with proven ability to collaborate cross-functionally and manage diverse stakeholders.
- Proactive, analytical, and solution-oriented mindset to identify and resolve challenges efficiently.
- Proficiency in planning, executing, and monitoring projects to ensure delivery within scope and timelines.
- 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).
- Extensive experience managing teams and/or projects, preferably in Regulatory Affairs and within pharmaceutical or related industries.
- In-depth knowledge and hands-on experience in regulatory affairs, including regulatory strategy development and product lifecycle management.
Skills
- Leadership & Team Management
- Organizational Skills
- Communication
- Problem-Solving
- Project Management
- Compliance Orientation
Experience Level
- Senior Manager
- Workday Global Grade: 18
Education Level
- Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering)
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 committed to integrity, driving innovation, making a remarkable impact on people's lives, and contributing to our communities.
- We actively support individuals with disabilities in our pursuit of equal employment opportunities.