Biibhr

Regulatory Lead

Japan · Hybrid · Full time

Apply on the employer’s site ↗See how well you match this job

You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.

About the role

Description from the employer’s posting. Check the employer’s page for the current version.

EmployerBiibhr
LocationJapan
Work styleHybrid
Employment typeFull time
Employer posted15 Jun 2026

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.

Show full description

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.

See how well you match this job Apply on the employer’s site ↗

Check your resume against this job Free, no sign-up. Nothing you paste is stored.

Staying safe while you apply

Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.

Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.

Preparing for this role with ROLIVA

Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
Prepare honestly.
Build interview stories and application drafts from your own evidence.
Keep track.
Save the role and record your own application status and follow-ups.

Create a free workspace or log in.