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Job Function:
Communications & Corporate/External Affairs
Job Sub Function:
Government Affairs & Policy
Job Category:
People Leader
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
Key Responsibilities for Japan Policy Role:
- Lead Japan regulatory policy strategy, identify and creating strategies to advance potential changes in the regulatory environment and initiatives that are relevant for J& J pharmaceutical products in Japan, as well as understanding the impact across the Asia-Pacific (AP) region.
- Provide GRPI, GRA, AP and China RA with strategic insights to help with internal understanding of regulatory initiatives, and external engagement to help shape regulatory approaches.
- Partner with China RA and AP RA to align with global and regional regulatory policy priorities.
- Drive policy strategic approaches for Japan RA.
- Integrate global regulatory policy strategies with specific Japan needs.
- Coordinate appropriate Japan participation in Trade Association initiatives, as well as regulatory commenting on new guidance documents and regulatory programs.
- Provide expert guidance and interpretation of key regulatory policy issues affecting Japan, the global landscape and the AP region.
Regulatory Policy Alignment with Global and Regional APAC Roles and Responsibilities:
- Integrate Japan Regulatory Policy priorities and activities with Global and APAC RA regional advocacy approaches.
- Implement effective advocacy strategies for Japan, aligned with global and APAC regional regulatory policy activities as appropriate, generating policy positions and strategic plans.
- Collaborate with internal teams within Japan RA and cross functional partners, aligning as appropriate with AP Regulatory, Government Affairs, Legal, and subject matter experts on advocacy strategies for key regulatory topics.
- Facilitate participation of regulatory affairs and other subject matter experts in trade association committees and professional organizations.
- Coordinate and prepare input for health authority commentaries on regulatory guidance and programs to influence key healthcare initiatives.
- Keep internal stakeholders informed about current regulatory guidelines, procedures, and emerging initiatives.
Regulatory Knowledge Management Related to Regional APAC:
- Partner with GRPI members to share insights on relevant global regulatory policy initiatives.
- Partner with China and AP RA to address Japan issues are effectively included in the Health Authority regulatory commenting processes.
LT Membership:
Main Duties & Responsibilities
- Develop and drive strategic regulatory policy advocacy for Japan GRPI, including development of strategic plans and policy positions.
- Align with China and AP RA advocacy activities, and with global approaches
- Successfully engage with cross-functional leaders within GRA, JRD, and other functions on advocacy strategic plans, including commenting on health authority programs.
- Provide leadership to the GRPI team, and drive appropriate participation in external and internal policy initiatives.
Requirements
Required Qualifications
Education: Bachelor’s degree in scientific discipline
Work Experience: min. 5 years in Japan pharmaceutical industry or Health Authority, min. 5 years in Japan Regulatory Affairs or Policy
Technical/ Professional Knowledge, Skill, Ability: Excellent working knowledge of the Japan regulatory framework, and understanding of APAC and global regulatory frameworks, and how those apply to pharmaceutical development.
Leadership Capability/ Skills:
- Pursues the highest standards of quality, safety, compliance, and ethics
- Seeks, listens to and incorporates diverse points of view
- Courageously tries new things, tests and learns from mistakes
- Develops self and others to reach their goals
- Engages in open and honest conversations
- Drives performance by managing energy and taking ownership for outcomes
- Proactively identifies needs of the global GRPI team and ensures that needs of GRPI are addressed according to team priorities and requirements.
Languages: Business level proficiency in English and Japanese
Preferred Qualifications
Education: Master’s degree in scientific discipline
Work Experience: 10+ years in pharmaceutical industry, 3-5+ years in Regulatory Affairs or Policy, Regulatory or Policy Experience at Health Authority, Solid understanding of the global regulatory environment, including in US, EU, and AP
＜ For Internal Applicants＞
- 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 Japan’s 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.
Please see the job description for required or recommended skills.
Please see the job description for benefits.