Manager of Post Marketing Regulatory Affairs/ Biopharma (Tokyo)

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。

Position title:   Manager of Post Marketing Regulatory Affairs

Location： Tokyo, Japan

Department:    Global Regulatory Affairs Japan

Reporting to:   Lead of Post Marketing Regulatory Affairs

Direct report:　0

The Role / Key Accountabilities

• Represent Regulatory Affairs (RA) in the responsible project team for the end-to-end activities from the initiation the regulatory strategy to the post-marketing after obtaining the marketing approval of the responsible projects.

• Lead the preparation of regulatory documents to be submitted Japanese Health Authorities.
• Negotiation with the regulatory authorities throughout face-to-face advice meeting, and the communication related the deliberations of PCA, GMP inspection and Japanese package insert revisions.
• Evaluation and cross-functional collaboration for Artwork, promotional material, and CMC variation control, etc. in view of RA.

• Support and supervise RA members.
• Conduct RA functional training.

• Contribute to improve quality and efficiency of any RA-related tasks, i.e., find issues, propose solution, act for improvement.
• To evaluate/interpret any changes of regulatory requirements in Japan and to implement the RA activities properly/timely.
• Review and provide regulatory input to promotion materials.

Who you are

Education and work experiences:

• Life science related discipline, e.g., pharmacy, biochemistry, medicine, veterinary medicine, etc.
• 10 or more years of experience in regulatory affairs

• Have extensive and broad experience in regulatory affairs not only development but also post-marketing in pharmaceutical company.

• Harmonization and Collaboration with global/local project team.
• Expertise in the development and management of regulatory strategy under the Japanese regulations and works with global/local subject matter experts to prepare and lead regulatory submission documents.

Competencies and skills:

• Sufficient knowledge, understanding and ability for creating development and post marketing/regulatory strategy taking various situation of each project and business impact into account.
• Fully understand what needs to be considered at each stage of development/post marketing and when preparing documents to be submitted to regulatory authorities, and what approaches are available to deal with problems.
• Good sense of balance in regulation, science and quality compliance.
• Communication and negotiation skill to build cross-functional relationship.
• Leadership and management skills in the functional and cross-functional team
• Good sensitivity of potential risk and planning of its risk management.
• Business-orienting thinking.
• Sufficient English Level
• Willingness and interest to take on the challenge of the following activities (preferable):

• Develop regulatory strategy for the responsible project.
• Develop submission plan and manage/coordinate preparation of regulatory documents, i.e., briefing document for PMDA consultation, CTN document, JNDA document CTD, etc.
• Create Health Authorities (HAs) interaction plan and represent the Company in project-related interactions with HAs.
• Review and provide regulatory input to all regulatory documents and authoring responsible parts of regulatory documents, e.g., CTD Module 1, consultation application form, briefing document, etc.

Recruiting contact: Fang Liu

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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 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!