Experience Inc. Jobs

Home View All Jobs (2,200,360)

Job Information

ThermoFisher Scientific Regulatory Affairs Manager in Tokyo, Japan

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

Educa tion and experience

  • 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

Knowledge, Skills, Abilities

  • 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

DirectEmployers