Senior Manager, Regulatory Affairs

About the role

Biogen is looking for a Senior Manager, Regulatory Affairs based in Tokyo. The role contributes to developing and implementing regulatory strategy for specific projects, acts as the regulatory representative from Japan on project teams and as the regulatory contact with relevant authorities, and manages the preparation of submission documents and approval of new drugs, including life cycle management in Japan.

Key responsibilities

• Lead the development, alignment and implementation of Japan's regulatory strategy for assigned projects and programs across all stages of development (pre-Phase 1 through commercial), integrating local requirements, global objectives, business priorities and emerging regulatory trends.
• Provide end-to-end leadership for regulatory submissions in Japan, setting the submission strategy, driving cross-functional execution, resolving issues and competing priorities, and keeping submissions aligned with global project plans and Japan business objectives.
• Lead meetings and interactions with Japanese health authorities, articulate the company's regulatory rationale and turn authority feedback into clear actions and recommendations.
• Identify, assess and communicate regulatory risks and opportunities, develop mitigation and escalation strategies, and influence project and functional leadership decisions.
• Recommend compliant approaches while weighing the risks and benefits of innovative ones, proposing solutions that go beyond conventional precedents.

Required profile

• Bachelor's degree required; Life or Health Sciences preferred.
• 10+ years of biotechnology or pharmaceutical experience.
• 5-7 years' experience in regulatory affairs or equivalent experience/education.
• Clinical research and drug development experience preferred.