Johnson & Johnson K.K. Medical company is recruiting for a Regulatory Affairs Specialist, Ethicon position, located in Tokyo.
Regulation related work for new product registration and existing products in biosurgery platform.
- New product registration related work for both pharmaceutical products and medical device (PMDA consultation, application for approval, application for certification, notification)
- Input local requirements to the design owner located in foreign countries.
- Collect all necessary information/data for the product registration from the design owner, etc.
- Create and execute the regulatory strategy
- Provides solutions to a variety of problems
- Regulatory assessment for changes for registered products.
- Execute regulatory actions for changes for registered products. .
- All other operations and administrative response related to regulatory compliance based on the Pharmaceutical and Medical Device Act.
- Review the promotional materials.
- Bachelor’s degree or higher.
Experience and Skills:
- English – business level (TOEIC 800 or above)
- Work experience as regulatory affairs specialist in the pharmaceutical and/or medical device industry
(5 years or more. Experience in CMC area / blood-derived products is highly preferable.)
- Deep knowledge of PMD Act and high compliance awareness
- Logical thinking
- Excellent communication skill in both Japanese and English
- Work experience in CMC area including GMP submission.
- Work experience in submitting the registration file for the products developed in foreign countries
- Work experience in submitting the registration file for combination products
- Take an action proactively
- Global mindset
- Build good relationship with various stakeholders
- Travel (local/global) percentage: less than 10%
*Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).