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About the Role
This hybrid role focuses on Regulatory Policy & Intelligence in Japan, with additional responsibilities in Development Regulatory Affairs for selected programs. It involves leading regulatory policy strategy, intelligence gathering, and engagement with authorities and industry stakeholders, while also serving as a Development Regulatory Affairs representative on Japanese Clinical Development Teams.
Responsibilities
- Serve as a Japan Regulatory Policy & Intelligence lead, providing strategic regulatory and legislative insight.
- Monitor, analyze, and interpret Japanese regulatory, legislative, and policy trends.
- Lead and support regulatory policy advocacy activities with PMDA, MHLW, and other relevant authorities.
- Represent the company in industry associations, committees, and working groups.
- Establish and maintain strategic networks with regulatory authorities, KOLs, and industry stakeholders.
- Provide timely regulatory intelligence and policy insights to internal and global stakeholders.
- Support internal capability building through training and knowledge sharing.
- Serve as a core member of Japanese Clinical Development Teams, providing Japan-specific regulatory strategy input.
- Define, refine, and communicate Japanese regulatory strategies and target labeling.
- Provide regulatory input on clinical development plans.
- Lead or support interactions with Japanese Health Authorities.
- Contribute to the planning, preparation, and execution of Japanese regulatory submissions.
- Participate in CTD preparation teams and cross-functional teams.
- Support responses to Health Authority questions.
- Support development and maintenance of Japanese target labels.
- Collaborate with 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 policy-level regulatory strategy and product-level execution in Japan.
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.
Skills
- Advocacy Communications
- Budget Management
- Community Outreach
- Compliance Management
- Corporate Communications Strategy
- Corporate Management
- Government Relations
- Leverages Information
- Mentorship
- Negotiation
- Organizing
- Public Affairs
- Public Policies
- Regulatory Development
- Relationship Building
- Representing
- Stakeholder Engagement
- Technical Credibility
Location
- Chiyoda, Tokyo, Japan
Work Type
- Hybrid
Experience Level
- Associate Director/Manager
About the Company
- At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Equal Opportunity
- As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.