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

Posté 21 août 2022

Tokyo, Tokyo - Japan

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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.




Title: Senior Manager of Post Marketing Regulatory Affairs

Direct report: 1~2

Reporting to: Head of Global Regulatory Affairs Japan

Work Location: Tokyo


Key Accountabilities:

  • To lead post marketing RA Group in GRA Japan.
  • To lead PMRA activities (e.g. Health Authority action of CMC variation control (sNDA/minor change notification), Drug Master file, GMP inspection, revision of Japanese Package Insert and control of artwork, review of promotion material) properly and accurately as the life cycle management activity
  • To share the regulatory requirements related to PMRA activities in Japan with relevant departments for adjusting business properly/timely
  • Take responsibility to improve PMRA capabilities and to increase efficiency in our internal processes
  • People development (e.g. provide the chance of training and coaching to increase their skills and competencies)


Candidate Profile:

Education and work experiences:

  • Professional experience in Post marketing Regulatory Affairs (10 years and more ideally) in pharmaceutical company
  • Solid understanding of J-PI, promotion material review, GQP, CMC variation control (MUST TO HAVE) as the role of post marketing Regulatory Affairs
  • New product RA experience preffered.
  • Pharmacist (nice to have)
  • Experience and capability to manage a certain number of team member including staff development


Competencies and skills:

  • Good sense of balance in regulation, compliance, science and business-oriented thinking
  • Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required
  • Logical thinking
  • Good sensitivity of potential risk and risk management in business compliance and quality
  • Ability to work diligent in order to ensure required document quality
  • Leadership to execute cross-functional collaboration
  • Goal-oriented approach and willingness to take ownership


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!