level-one heading

Kolabtreeを選ぶ理由

開始はすばやく簡単です。初期費用はかかりません。

サービス依頼と専門家への見積依頼は無料です。

Kolabtree の作業範囲に同意する前に、専門家と要件を詳しく相談できます。

専門家と直接連携し、必要な成果を正しく得られます。

専門家を採用したらプロジェクトに資金を入れ、作業完了後に成果物を承認できます。

JUNYA N. に連絡

連絡する

Kolabtreeを選ぶ理由

この専門家をプロジェクトに採用したいですか？見積もりを依頼無料で。

プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

JUNYA N.に依頼

Japan

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

プロフィール概要

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.]

専門分野

サービス

Writing
Consulting

Writing Clinical Trial Documentation, Translation

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

職務経験

PRODUCT SAFETY MANAGER

Freyr Solutions

1月 2025 - 現在

Head of Quality Assurance / General Marketing Supervisor

JUST MATCH Corporation (Medical Device Sales & Manufacturing)

12月 2022 - 2月 2023

Senior Quality Assurance Manager

Nippon Becton Dickinson Company, Ltd.

1月 2019 - 6月 2019

Manager of Regulatory Affairs Operations

Integrated Development Associate KK

5月 2018 - 12月 2018

Head of Pharmacovigilance and Safety

Teva Pharmaceutical K.K.

12月 2013 - 5月 2018

Product Quality & Post-Marketing Safety Manager

Precision System Science Co., Ltd.

7月 2012 - 3月 2013

Post-Marketing Quality & Safety Manager

Kyocera Corporation (Kyocera Medical)

7月 2003 - 2月 2012

Clinical Trial Manager

Global Pharmaceutical Inc., Tokyo

8月 2002 - 1月 2003

Drug Safety Researcher (Pharmacovigilance)

The Nisshin Oil & Mills, Ltd., Tokyo

4月 1992 - 1月 1999

学歴

Master of Arts (M.A.)

University of Western Sydney - Australia

3月 2000 - 4月 2002

Bachelors

Saitama University - Japan

4月 1988 - 3月 1992

認定資格

ISO 13485 Internal Auditor

TUV

12月 2012 - 現在