Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job title: Regulatory Affairs Manager

Thermo Fisher Scientific Inc. is seeking a highly motivated individual to join our world-class team as a Regulatory Affairs Manager in Japan. As a global leader in scientific research, we are dedicated to making the world healthier, cleaner, and safer.

Your work will have real-world impact, and you'll be supported in achieving your career goals.

Responsibilities

• Develop and implement regulatory strategy's across companion diagnostic projects to ensure that company products are safe, legal and meet expectations with regulations.
• Prepare documents for In vitro diagnostic regulatory filings and agency consultation materials under PMD Act.
• Represent the Regulatory Affairs function at internal multi-departmental project meetings
• Represent the Regulatory Affairs function while interacting with project pharmaceutical partners
• Interact 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.
• Review advertising and promotional materials

• Bachelor's degree or above for chemical, pharmaceutical, medical, science, etc.
• 3-6 years Regulatory experience in the IVD or medical device industry
• Experience representing the regulatory function on project teams
• Product submission experience is a plus

• Ability to plan multiple tasks and effectively prioritize activities
• 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)
• Pharmacist license holder preferred but not required