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
Qualifications
Bachelor’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
