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Senior Manager of Post Marketing Regulatory Affairs/ Biopharma (Tokyo)
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.
Title: Senior Manager of Post Marketing Regulatory Affairs
Direct report: 1～2
Reporting to: Head of Global Regulatory Affairs Japan
Work Location: Tokyo
- 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)
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