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。

JOB DESCRIPTION

 

Position title:   Regulatory Affairs Manager

Department:   Global Regulatory Affairs Japan

 

Key Accountabilities:

Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Manager will focus on some of the following activities in Regulatory Affairs Group 1 or Group 2:

Lead RA-related Health Authority (HA) interactions.   e.g., PMDA Consultation, Clinical Trial Notification (CTN), etc.Lead New Drug Application (NDA) and supplementary NDA (sNDA) such as indication expansion, new formulation, etc.Lead preparation of the Japan NDA activities and HA’s review for approval.Prepare the Japan-CTD regulatory parts such as Approval Application Form, Module 1, etc.Manage Partial Change Application (PCA)/Minor Change Notification (MCN) [Change Control Process/Post-marketing activities] with collaborative with CMC team.Lead electronic Japanese Package Inserts (J-PI), respond to query, and join artwork activities. Review promotion materials.Manage Outsourcing vendors as needed.Represent RA for the SOPs/WI updates and improvement tasks.

Candidate Profile:

Education and Preferable work experiences:

Experiences in R&D such as Regulatory Affairs.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 J-RA representative.Stakeholder management: Communication/coordination, leadership/ownership skills, strategic consideration and project/risk management skills (e.g., To Clarify regulatory risks and plan/execute minimization/mitigation).

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 celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Apply now and become a part of our diverse team!