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About the Role

This role focuses on regulatory affairs and safety management for pharmaceutical and regenerative medicine raw materials, medical devices, in-vitro diagnostic reagents, and animal health drugs. You will be responsible for Drug Master File (DMF) registration and change management, as well as ensuring compliance with various regulations.

Responsibilities

• Manage new DMF registrations and changes for raw materials used in pharmaceuticals and regenerative medicine, in collaboration with global teams.
• Respond to inquiries from DMF applicants and regulatory authorities.
• Manage changes to package inserts and labels for medical devices, in-vitro diagnostic reagents, and animal health drugs.
• Handle change notifications and ensure compliance with PMDA website postings.
• Evaluate change notifications from manufacturers for medical devices, in-vitro diagnostic reagents, and animal health drugs, and perform necessary regulatory procedures.
• Create and manage product labeling.
• Collect, evaluate, and report adverse events (medical devices) and side effects (in-vitro diagnostic reagents, animal health drugs) to authorities in coordination with the safety manager.
• Develop and implement safety measures as needed.
• Operate and manage GVP procedures.
• Monitor and assess regulatory changes obtained through industry associations, and communicate them internally.
• Determine the necessity of internal responses to regulatory changes.
• Act as a liaison with industry associations.

Requirements

• Bachelor's degree in a science field (e.g., Pharmacy, Chemistry, Biology, Engineering).
• Over 3 years of experience in regulatory affairs or quality assurance at a pharmaceutical or medical device manufacturer, raw material manufacturer, or contract manufacturing organization (CMO).
• Ability to create, read, and respond to regulatory documents in Japanese and communicate with authorities.
• Ability to communicate via email and read regulatory documents in English.

Skills

• Regulatory Affairs
• Quality Assurance
• Drug Master File (DMF) Registration
• Change Management
• GVP (Good Vigilance Practice)
• Regulatory Compliance
• Medical Device Regulations
• In-Vitro Diagnostic Regulations
• Animal Health Drug Regulations
• Pharmaceutical Raw Material Regulations
• Regenerative Medicine Regulations
• Communication (Japanese and English)
• Document Creation
• Regulatory Document Reading
• Authority Communication
• Global Collaboration

Location

• Mita Headquarters

Work Type

• Hybrid Work
• Flexible Schedule

Experience Level

• Staff Level (Band 1-5)

Education Level

• Bachelor's Degree in Science

Benefits

• Flexible work arrangements
• Remote work options

About the Company

• Thermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $40 billion and 125,000 employees worldwide.
• The company's mission is to enable customers to make the world healthier, cleaner, and safer.
• Thermo Fisher Scientific supports customers in accelerating life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and therapies.
• The company's industry-leading brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Equal Opportunity

• Thermo Fisher Scientific is an Equal Opportunity Employer.
• All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
• Reasonable accommodation will be provided to individuals with disabilities during the application and employment process.