Regulatory Operation Manager

Work Your Magic with us! 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day.

メルクは、ヘルスケア、ライフサイエンス、エレクトロニクスの分野における世界有数の企業です。サイエンスとテクノロジーへのあくなき探究から生まれる革新的な製品・サービスで人々の豊かな暮らしを創造します。

メルクグループジャパンについて、こちらをご参照ください。

Position title:   Regulatory Operation Manager

Department:   Global Regulatory Affairs Japan

Report to:       Head of Global Regulatory Affairs Japan

Key Accountabilities:

Develop and execute regulatory affairs (RA) activities throughout the development and life cycle management phases, in collaboration with global and Japanese stakeholders.

Regulatory Operation Manager focuses on leading regulatory submission dossiers preparation and to implement and manage global and Japan regulatory systems, especially from a view of technical and compliance.

• Lead and coordinate regulatory dossier preparation processes in collaboration with global and Japanese stakeholders.
• Coordinate Japanese CTD preparation and manage the Table of Contents of the J-CTD with the Japan Regulatory Affairs Manager and global regulatory.
• Organize CTD/eCTD workspace for dossier preparation team
• Submit the eCTD to Japan Health Authority in collaboration with the Japan Regulatory Affairs Manager.
• Lead outsourcing vendors for eCTD development, including document publishing.
• Input the latest eCTD requirement in Japan to the global team.
• Lead the implementation of regulatory IT systems and contribute to the maintenance of regulatory system quality and compliance.

Candidate Profile:

Education and Preferable work experiences:

• Experiences of regulatory submission dossier preparation
• Experiences of regulatory IT systems such as VEEVA
• Experiences of Collaborating with cross-functional team and global member.

Competencies and skills:

• Language: Japanese- native level. English: Able to communicate with global members as the Japan representative.
• Stakeholder management: Communication/coordination, leadership/ownership skills, strategic consideration, and project/risk management skills.

Recruiting Contact: Maiko Yamasue

Register now to our new Talent Zone! It is a great way to stay connected, learn more about our company, career opportunities and events! Even you have no plan to apply a position now, please feel free to register to be visible to our internal recruiters and stay in touch for future opportunities.

メルクグループのタレントゾーンにご登録ください！メルクのポジションにすぐに応募予定のない方も登録可能です。

メルクグループと、メルクにおけるキャリアオポチュニティーについて、理解を深めるいい機会を是非ご活用ください！

Talent zone link: https://careers.vibrantm.com/global/en/jointalentcommunity

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!