Senior Manager, Regulatory Affairs

Job Overview:

Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative from Japan on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

Manage the process for preparation of submission documents and approval of new drugs including life cycle management in Japan.

Not only as a regulatory matter expert, proactively collaborate with stakeholders in R&D and lead project teams with them.

Job Duties:

・Responsible for leading the development, alignment, and implementation of Japan regulatory strategy for assigned projects and programs across all stages of development (pre-Phase 1 through commercial), integrating local regulatory requirements, global development objectives, business priorities, and emerging regulatory trends.

・ Provide end-to-end leadership for all aspects of regulatory submissions relevant to assigned projects or programs in Japan, establishing the submission strategy, driving cross-functional execution, resolving issues and competing priorities, and ensuring alignment with global project plans and Japan business objectives.

・ Lead the strategy, preparation, and conduct of necessary meetings and other interactions with Japanese Health Authorities for assigned projects, aligning cross-functional positions, articulating the company's regulatory rationale, and translating authority feedback into clear actions and strategic recommendations.

・ Identify, assess, and communicate regulatory risks and opportunities for assigned projects or programs; develop mitigation and escalation strategies, and influence project and functional leadership decisions by clarifying implications for development, approval, launch, and life cycle management in Japan.

・Provide recommendations that not only comply with regulatory requirements, but also carefully weigh the risks and benefits of pursuing innovative approaches and propose solutions that go beyond conventional precedents.

Minimum Education Requirements:

BA/BS/University degree required, Life/Health Sciences preferred.

Minimum Experience Requirements:

10  years+ biotechnology or pharmaceutical experience

5-7 years’ experience in regulatory affairs or equivalent experience/education

Strong understanding of regulation, guidelines and trends 

Clinical research and drug development experience preferred

 

Job Level: Management

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.