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About the Role

We are seeking a strategic, collaborative, and people-focused Head of Regulatory Affairs to lead regulatory strategy and operations for Japan, ensuring successful registration and life-cycle management of medicines. You will guide a team, partner with global colleagues, and serve as the appointed Marketing Supervisor General for Japan, overseeing quality assurance and post-marketing safety management.

Responsibilities

• Lead regulatory strategy and planning for Japan in alignment with Japan and global business objectives.
• Guide regulatory submissions and approvals for new products and life-cycle activities.
• Oversee regulatory project planning, performance indicators, and long-range planning.
• Build strong partnerships across functions in Japan and internationally.
• Manage the regulatory team’s budget, resources, and capability development.
• Promote regulatory understanding and compliance throughout the organization.
• Represent Japan in regulatory leadership forums and relevant industry associations.
• Drive regulatory intelligence, advocacy, and policy initiatives.
• Attract, develop, and retain a high-performing regulatory team.
• Serve as the appointed Marketing Supervisor General, overseeing quality assurance and post-marketing safety management.

Requirements

• Licensed Pharmacist in Japan.
• Minimum 10 years in the pharmaceutical industry, with 8+ in regulatory affairs.
• Strong leadership and people management skills, including coaching and mentoring to create an inclusive collaborative team environment.
• Experience collaborating internationally and influencing senior stakeholders.
• Strong understanding of Japan regulatory requirements and development pathways.
• Demonstrated ability to lead teams and manage regulatory authority relationships.
• Ability to solve complex problems and drive cross-functional alignment.
• Strong communication skills to influence internal and external partners.

Location

• Nishi-Shinjuku, Tokyo, Japan

Work Type

• Full-time

Experience Level

• 8+ years in regulatory affairs
• 10+ years in the pharmaceutical industry

Education Level

• Licensed Pharmacist in Japan

About the Company

• UCB is a global biopharmaceutical company focusing on neurology and immunology.
• Approximately 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, we value creating value, not just doing work.
• We strive to achieve results for patients by embracing challenges, collaborating, and pursuing innovation.
• We foster a caring and supportive culture where everyone is respected, accepted, and has equal opportunities to do their best.
• We always aim for 'beyond,' delivering human-centered value to patients, employees, and the planet.
• Working at UCB allows you to experience personal growth, build your career freely, and reach your full potential.

Equal Opportunity

• UCB values equal opportunity.
• All hiring decisions are made regardless of any legally protected attribute.
• If you require special accommodations during the selection process, please contact EMEA-Reasonable_Accommodation@ucb.com.