Manager of Post Marketing Regulatory Affairs/ Biopharma (Tokyo) 1

Posted 09 Apr 2024

Tokyo, Tokyo - Japan

Req Id 273818

 

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 unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

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.

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

Location:         Tokyo

Department:   Global Regulatory Affairs Japan

Report to:     Senior Manager (In Japan)

Direct report:  0

 

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 members.

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).

 

Recruiting contact: Fang Liu



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 and believe that it 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 our diverse team!

 

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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

 

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