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Biogen

Regulatory Lead

1 week ago• Tokyo, Japan

Job Summary:

特定のプロジェクトチームの日本の薬事担当者として、薬事戦略の策定及び実施に積極的に貢献し、必要に応じて関連する規制当局と交渉を行う役割を担う。

日本のライフサイクルマネジメントを含め、新薬の承認申請資料の作成プロセスを管理する。

Job Duties:

  • 規制に関する十分な知識に基づき、開発の全段階（第I相以前から市販まで）において担当するプロジェクトやプログラムの薬事戦略の策定と実施に積極的に貢献する責任を負う。
  • 担当するロジェクト又はプログラムに関連し、規制当局との相談や申請業務を調整する責任を負う。
  • 担当するプロジェクトに必要な日本の規制当局との会議の手配と準備を行う
  • 担当するプロジェクト又はプログラムの薬事的リスクを特定し、評価する。
  • 薬事に対する理解を深め、プロジェクトに関わるチームに助言する 。

Minimum Education Requirements:

BA/BS/大学の学位が必要、ライフ/ヘルスサイエンスが望ましい。

Minimum Experience Requirements:

5年以上のバイオテクノロジー又は医薬品の経験

4～6年の薬事経験又はこれに相当する経験/教育

規制及びガイドラインに対する深い理解

臨床研究及び医薬品開発経験が望ましい

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.

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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.

Client-provided location(s): Tokyo, Japan
Job ID: Biogen-REQ23484
Employment Type: FULL_TIME
Posted: 2026-06-16T00:03:09

Perks and Benefits

  • Health and Wellness

    • FSA
    • HSA
    • On-Site Gym
    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • Mental Health Benefits
    • Fitness Subsidies
    • HSA With Employer Contribution

  • Parental Benefits

    • On-site/Nearby Childcare
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Adoption Leave

  • Work Flexibility

    • Remote Work Opportunities
    • Flexible Work Hours
    • Hybrid Work Opportunities

  • Office Life and Perks

    • Commuter Benefits Program
    • Happy Hours
    • Some Meals Provided
    • Company Outings
    • On-Site Cafeteria
    • Holiday Events

  • Vacation and Time Off

    • Leave of Absence
    • Personal/Sick Days
    • Paid Holidays
    • Paid Vacation
    • Sabbatical
    • Volunteer Time Off
    • Summer Fridays

  • Financial and Retirement

    • Relocation Assistance
    • Performance Bonus
    • Company Equity
    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling

  • Professional Development

    • Promote From Within
    • Access to Online Courses
    • Lunch and Learns
    • Tuition Reimbursement
    • Internship Program
    • Leadership Training Program
    • Mentor Program
    • Shadowing Opportunities

  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)