Regulatory Affairs Manager【Medical Device】

Tokyo 23 Wards 外資系企業 ¥9,000,000 - ¥13,000,000 per year Foreign Multinational Work from Home or Hybrid View Job Description
当社の薬事に関する業務
  • グローバルにご活躍いただけます!
  • フレックスタイム・在宅〇

About Our Client

スペシャリティファーマの未来をリードすることに全力を注いでいます。そのため当社は、ニュージャージーで成長を続けるスペシャリティブランド組織を拡大し、ミズーリ州セントルイスで私たちの伝統をさらに発展させ、アイルランドのダブリンにグローバル本社を設立しています。このようなグローバルな事業展開により、社員と製品ポートフォリオへの投資を継続し、世界中の患者さんの生活に永続的な変化をもたらすことができるのです。

Job Description

・ Holds responsibility for medical device(s) and supports the Global Regulatory Lead (GRL)/ in the development & execution of the regulatory strategy

・ In cooperation with Global Device Regulatory team, leads activities to develop and implement regulatory strategies to secure global medical device licenses and approvals.

・ Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned medical devices.

・Supports fore-mentioned regulatory activities for pharmaceutical products as needed.

The Successful Applicant

・ Japanese speaker, and also English capability especially in reading, writing and verbal communication skill

・ Bachelor degree; preferably in a pharmacy, scientific or technical field; advanced scientific-related degree strongly preferred

・ Medical devices (Class III or IV) regulatory activities experience.

・ Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.

・ Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.

What's on Offer

・正社員
・本社勤務
・フレックスタイム
・在宅勤務あり

Contact
Yui Hirabayashi
Quote job ref
JN-102024-6569441
Phone number
+813 6832 8651

Job summary

Function
Life Sciences
Specialisation
Medical Devices
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Tokyo 23 Wards
Job Type
Permanent
Consultant name
Yui Hirabayashi
Consultant phone
+813 6832 8651
Job Reference
JN-102024-6569441
Company Type
Foreign Multinational
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.