[Innovative Medicine] R&D, Associate DirectorManager, Global Regulatory Policy & Intelligence, Japan Regulatory Policy, Regulatory Affairs

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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 (JCDTs) providing regulatory strategy authority interaction and submission support for development compounds.
• The position integrates policylevel regulatory insight with productlevel 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 authorities key opinion leaders (KOLs) and industry stakeholders.
• Provide timely regulatory intelligence and policy insights to Japan R&D Japan RA GRPI and global stakeholders.
• Support internal capability building through training and knowledge sharing on regulatory policy and intelligence topics.

2. Development Regulatory Affairs Responsibilities (Formal Secondary Accountability)

• Serve as a core member of Japanese Clinical Development Teams (JCDTs) providing Japanspecific regulatory strategy input.
• Define refine and communicate Japanese regulatory strategies and target labeling to Global Regulatory Teams (GRTs) ensuring alignment with global strategies.
• Provide regulatory input on clinical development plans including study design Japanese requirements and the need for local or additional studies.
• Lead or support interactions with Japanese Health Authorities (PMDA/MHLW) including consultations preliminary meetings and developmentrelated discussions.
• Contribute to the planning preparation and execution of Japanese regulatory submissions including CTN and NDA activities.
• Participate in CTD preparation teams and crossfunctional teams to ensure submission quality and alignment with Japanese regulatory expectations.
• Support responses to Health Authority questions in collaboration with crossfunctional teams ensuring scientific rigor timeliness and consistency with approved strategies.
• Support development and maintenance of Japanese target labels in alignment with regulatory clinical and commercial strategies.

3. CrossFunctional and Global Collaboration

• Collaborate closely with Japan Regulatory Affairs R&D Medical Commercial and other internal functions to integrate regulatory policy and development perspectives.
• Partner with Global Regulatory Policy Leaders to facilitate regional and global regulatory alignment.
• Act as a bridge between policylevel regulatory strategy and productlevel execution in Japan.

EDUCATION EXPERIENCE & SKILL REQUIREMENTS:

• Extensive experience in the pharmaceutical industry R&D environment and/or regulatory authorities including regulatory affairs responsibilities.
• Strong working knowledge of the Japanese regulatory framework and practical experience with PMDA/MHLW interactions.
• Experience in both regulatory policy/strategy discussions and development regulatory execution preferred.
• Excellent verbal and written communication skills in both Japanese and English.
• Proven ability to operate effectively in a matrix organization and manage multiple stakeholders.
• Strategic thinker with strong execution capability capable of balancing policy leadership and development support responsibilities.

For Internal Applicants

• Based on your experience and interview evaluation the position title and level may vary.
• If you are Japan employee please read Internal Application Guideline in Ask GS. Especially if you are less than 18 months in your current role you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japans employee you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP) please read and understand the details of the Internal Referral Overview on the Ask GS and you have made a compliant referral.

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