Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About Us

Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

Essential Duties and Responsibilities

We are currently seeking a Regulatory Affairs Specialist to join Clinical Sequencing Division Regulatory Affairs Team. As a member of the Regulatory Affairs team, you will be development and implementation regulatory strategies across companion diagnostic project under the guidance of Senior Regulatory team members.

Job Description

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 reviewsMaintain 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

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 requiredExperience participating in projects involving multiple functionsDesire to develop a career in Regulatory Affairs.Detail orientedAbility to learn by doingEffective communicator with internal and external contactsProven ability to work under own initiative, and strong team playerFluent in Japanese. Business level in English (oral and written) a plusExperience 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 requiredPharmacist license holder preferred but not required