The incumbent will be responsible for independently supporting the regulatory assessment and market access efforts for Reduced-Risk Products (RRP) in the local market. This includes compiling scientific documentation in line with government requirements, collaborating with the Scientific & Regulatory Affairs team, preparing regulatory and health-related materials, and effectively communicating JTI's positions to relevant stakeholders. Operating autonomously, the role ensures regular updates to the line manager and contributes to strategies that manage regulatory risks and opportunities, all in compliance with JTI's Code of Conduct and Operating Guidelines.
As a RRP External Affairs Associate Manager, you will:
- Prepare scientific and regulatory documents for RRP products to support government submissions, while independently executing regulatory strategies and external affairs initiatives. Conduct internal assessments, produce detailed reports, and consistently keep the line manager informed of progress and key developments.
- Independently handle engagement with external stakeholders by preparing well-informed materials that reflect deep knowledge of the RRP category and Health Risk Assessment mechanisms. Strategically plan communication of JTI's positions, ensuring alignment with company direction through ongoing consultation and updates to the line manager.
- Build and sustain strong relationships with key external stakeholders by preparing engagement materials and managing outreach efforts. Continuously monitor stakeholder dynamics and regulatory developments, evaluate the impact of RRP External Affairs programs, and provide regular updates and recommendations to the line manager.
- Execute approved RRP External Affairs strategies by creating effective communication materials and managing related internal and external activities. Ensure timely and consistent delivery of JTI's positions, while staying aligned with strategic direction through regular updates and coordination with the line manager.
- Establish and lead effective collaboration with internal teams to compile scientific dossiers for RRP product market access and ensure adherence to post-market surveillance requirements. Take full responsibility for advancing broader business and RRP goals, while keeping the line manager regularly updated on progress and critical matters.
Requirements:
- Postgraduate degree in Public Health, Regulatory Affairs, Health Sciences, or a related discipline
- Minimum of 5 years of relevant experience, preferably in the pharmaceutical industry or clinical research
- Strong understanding of scientific documentation, papers and terminologies
- Proven experience in preparing and submitting regulatory documents to Taiwan government agencies such as FDA, HPA, and NHIA
- Familiarity with regulatory processes and compliance standards in Taiwan
- Proficient in English, both written and verbal