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Hire JUNYA N.

Japan

USD 50 /hr

Regulatory & QA Consultant | 25+ yrs in Global Pharma & MedTech | Proven Track Record in New Drug Approval & Global Audi

Profile Summary

Working as a freelance Safety Manager, I am responsible for overseeing pharmacovigilance activities and ensuring compliance with Japanese pharmaceutical and medical device regulations, including the PMD Act, GVP, and GPSP. I provide strategic consultation to international clients, supporting regulatory submissions and adverse event reporting in alignment with global safety standards.

Additionally, I assist foreign manufacturers with registration procedures required by the Japanese Regulatory Authority, ensuring smooth market entry and ongoing compliance. My role also involves preparing bilingual safety documentation and engaging directly with overseas stakeholders to clarify Japan-specific regulatory expectations.

Selected Publications (Unlisted Author Contributions):

• Glatiramer acetate: Review of long-term safety and efficacy in relapsing-remitting multiple sclerosis.  
  Bio Clinica, 2014; 3(1):129–135.  
  [Contributed to the Japanese regulatory section, including PMDA documentation and local medical adaptation. Not listed as an author per publication policy.]

Subject Matter Expertise

Services

Writing
Consulting

Writing Clinical Trial Documentation, Translation

Consulting Go-to-Market Strategy Consulting, Healthcare Consulting, Regulatory Consulting

Work Experience

PRODUCT SAFETY MANAGER

Freyr Solutions

January 2025 - Present

Head of Quality Assurance / General Marketing Supervisor

JUST MATCH Corporation (Medical Device Sales & Manufacturing)

December 2022 - February 2023

Senior Quality Assurance Manager

Nippon Becton Dickinson Company, Ltd.

January 2019 - June 2019

Manager of Regulatory Affairs Operations

Integrated Development Associate KK

May 2018 - December 2018

Head of Pharmacovigilance and Safety

Teva Pharmaceutical K.K.

December 2013 - May 2018

Product Quality & Post-Marketing Safety Manager

Precision System Science Co., Ltd.

July 2012 - March 2013

Post-Marketing Quality & Safety Manager

Kyocera Corporation (Kyocera Medical)

July 2003 - February 2012

Clinical Trial Manager

Global Pharmaceutical Inc., Tokyo

August 2002 - January 2003

Drug Safety Researcher (Pharmacovigilance)

The Nisshin Oil & Mills, Ltd., Tokyo

April 1992 - January 1999

Education

Master of Arts (M.A.)

University of Western Sydney - Australia

March 2000 - April 2002

Bachelors

Saitama University - Japan

April 1988 - March 1992

Certifications

ISO 13485 Internal Auditor

TUV

December 2012 - Present

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