About this opportunity
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.
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.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 554 comparable Regulatory Affairs roles across 108 biopharma companies.
Salary context
152 of 554 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 554 comparable roles
+ 43 more countries
Seniority mix
432 of 554 peers have a known seniority level
Therapeutic area mix
44 of 554 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Regulatory Affairs job in Japan, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.