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Regulatory Affairs Specialist II
Thermo Fisher ScientificTokyo, Tokyo, Japan30+ days ago
Job descriptionBachelor’s degree or above for chemical, pharmaceutical, medical, science, etc. Minimum 1 yr experience working in Bioscience Research, Pharmaceutical, Healthcare or other Biotech industry is a plus but not required Experience participating in projects involving multiple functions Desire to develop a career in Regulatory Affairs. Detail oriented Ability to learn by doing Effective communicator with internal and external contacts Proven ability to work under own initiative, and strong team player Fluent in Japanese. Business level in English (oral and written) a plus Experience with Microsoft office applications (outlook, excel, power point, word) Regulatory experience in the in vitro diagnostics, medical device or pharmaceuticals is a plus but not required Pharmacist license holder preferred but not required
Under the guidance and direction of Senior RA team members :
- Support the development and implementation regulatory strategies across companion diagnostic projects to ensure that company products are safe, legal and meet expectations with regulations.
- Prepare documents for In vitro diagnostic / medical device regulatory filings and agency consultation materials under PMD Act.
- Participate as one of the regulatory affairs team members in project meetings (internal and external)
- Join team’s interaction with PMDA during product regulatory reviews
- Maintain regulatory documents to keep registration status.
- Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies.
- Participate in the review of advertising and promotional materials
Qualification
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Regulatory Specialist • Tokyo, Tokyo, Japan