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

Posted 21 Aug 2022

Tokyo, Tokyo - Japan

Req Id 254397

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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.

 


JOB DESCRIPTION

 

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. 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!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html


Careers during Covid-19

Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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