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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Summary

Join Thermo Fisher Scientific Diagnostics K.K. as an extraordinary Regulatory Affairs Specialist II, an outstanding opportunity to contribute to our world-class Regulatory Affair team in Japan. You will be instrumental in ensuring that our innovative products and services meet the highest standards of safety and compliance, helping us make a global impact.

Job Responsibilities

• Provide expert advice and suggestions to ensure new products, services, and activities comply strictly with national regulations.

• Plan and successfully implement regulatory strategies based on project plans.

• Communicate regularly with collaborators both internationally and domestically to acquire essential information for pharmaceutical applications.

• Prepare and review registration documents and labeling materials for in vitro diagnostics and medical devices.

• Undertake updates and changes to relevant licenses in a timely manner.

• Consult with regulatory authorities (MHLW, PMDA, certification bodies, prefectures, public health centers) as necessary.

• Advise on pharmaceutical strategies for clinical research, confirm data, and support ethical reviews.

• Collaborate with QA teams to respond to QMS auditing by authorities.

• Maintain and continuously improve processes to ensure compliance with regulatory standards.

Necessary Skills

• Proven ability to connect effectively with Japanese and foreign peers.

• Ability to plan multiple tasks and prioritize activities flawlessly.

• Detailed understanding of the Pharmaceutical and Medical Devices Law.

• Competence in accurately understanding and compiling test reports.

• Proficiency in reading and writing English for international communication.

• Familiarity with other essential laws and guidelines (Poisonous and Deleterious Substances Control Act, Industrial Safety and Health Act, PRTR-SDS Act, Ethical Guidelines, etc.).

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.