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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.
Manager of Post Marketing Regulatory Affairs
Post Marketing Regulatory Affairs
Global Regulatory Affairs Japan
Senior Manager of Post Marketing Regulatory Affairs Japan
- To ensure post-approval regulatory activities properly as a life cycle management:
- Health Authority activities in CMC variation control, Drug Master File, GMP inspection
- Control of artwork including J-PI revision
- Review of promotional materials (Preferred)
- To lead the task team in PMRA activities timely and properly
- To create Health Authority interaction plan and execute productive communication with Japanese regulators in line with company strategy
- To evaluate/interpret any changes of regulatory requirements in Japan and to implement the PMRA activities properly/timely
- To conduct the functional training to maintain the KPI of PMRA
Education and work experiences
- Bachelor above degree in science
- 2 or more years of experiences in PMRA activities in pharmaceutical industry or equivalent
- Expeience of Regulatofy CMC variation must to have.
- New drug RA experience preffered.
- Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required
- Experiences of strategic discussion for regulatory approach with the Japanese regulators
Competencies and skills
- Good sense of balance between science, regulation and document quality
- Communication skill to build cross-functional relationship
- Good sensitivity of potential risk and risk management
- Project management skill
- Ownership and accountability
- Business-orienting thinking
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