[Innovative Medicine] R&D, Associate Director/Manager, Global Regulatory Policy & Intelligence, Japa

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Job Function:
Communications & Corporate/External Affairs

Job Sub Function:
Government Affairs & Policy

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Associate Director/Manager, Japan Regulatory Policy (with Development Regulatory Affairs Responsibilities)

POSITION SUMMARY:


* This position is a hybrid Regulatory Affairs role with primary responsibility for Regulatory Policy & Intelligence in Japan and formal responsibility for Development Regulatory Affairs activities for selected development programs.


* The role reports directly into the Japan Regulatory Policy & Intelligence function, leading regulatory policy strategy, intelligence generation, and strategic engagement with regulatory authorities and industry stakeholders in Japan.


* In parallel, the role serves as a Japan Development Regulatory Affairs representative on Japanese Clinical Development Teams (J‑CDTs), providing regulatory strategy, authority interaction, and submission support for development compounds.


* The position integrates policy‑level regulatory insight with product‑level development execution, ensuring alignment between evolving regulatory frameworks, development strategies, and business objectives, while contributing to public health outcomes in Japan.

PRINCIPAL RESPONSIBILITIES:

1.

Regulatory Policy & Intelligence (Primary Accountability)


* Serve as a Japan Regulatory Policy & Intelligence lead, providing strategic regulatory and legislative insight relevant to drug development and commercialization in Japan.


* Monitor, analyze, and interpret Japanese regulatory, legislative, and policy trends, assessing their impact on R&D portfolios and development strategies.


* Lead and support regulatory policy advocacy activities with PMDA, MHLW, and other relevant authorities in collaboration with Global Regulatory Policy & Intelligence.


* Actively represent the company in industry associations, committees, and working groups (e.g., JPMA, PhRMA), contributing to policy development and regulatory discussions.


* Establish and maintain strategic networks with regulatory au...