INNOVATIVE MEDICINE] R&D, ASSOCIATE DIRECTOR, RA POLICY & INTEL JAPAN, REGULATORY POLICY INTELLIGENCE GROUP, REGULATORY DEVELOPMENT DEPT.

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POSITION SUMMARY.
Drive and manages the activities of Regulatory Intelligence as the representative of Japan RA and related Japanese function within R&D, such as proactively driving Industry Association or Health Authority (HA) interactions to successfully develop the Janssen compounds or raise Japanese presence among industry or to HA.
Lead and administrate the strategical discussion from the perspective of the contribution to both of public health and our business.
Lead the identification of regulatory and legislative trends and issues that have the potential to impact the development and marketing of pharmaceutical products within Japan and provide high quality strategic input aimed at influencing the future regulation.
Japan Regulatory Policy Lead to engage in direct regulatory advocacy and influencing activities relating to regulatory healthcare policies partnering with stakeholders including local subject matter experts and AP/GRPI.
This is accomplished through a variety of activities, including participation in Trade Association initiatives, Health Authority meetings and consultation as well as contribution to commenting on new legislation and guidance.
PRINCIPAL RESPONSIBILITIES.
Regulatory Policy Japan Expertise - Provide leadership for proactive & reactive policy development internally and externally Provide leadership for key Trade Associations and Professional Organizations Provide expert advice on and interpretation of key regulatory policy issues affecting local environment Develop effective approaches to and participate in Trade Association Committees and Initiatives, Professional Organizations activities and Health Authorities meetings and consultations.
Advice and Cooperative to RCLs activities for policy focused projects (ex, Regenerative medical products etc) - Attend and provide feedback to RCLs and R&D members on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact or affect products.
Attend and provide feedback to RCLs and R&D members on local regulation of new business area.
Collect opinions from R&D activities and liaise with Trade Associations to bring them up to Working Group with HAs Cooperative to regulatory policy and intelligence based on Japan regulation to AP/GRPI, R&D and JJ MedTech - Collaborate and partner with AP/GRPI and Japan RA/R&D members to ensure effective and timely dissemination of Regional Regulatory Information, Intelligence and Knowledge Collaborate regulatory members in JJKK to share Regional Regulatory Information, Intelligence and Knowledge Negotiation with HA, KOL and stakeholder for suitable issue.
Establish network of MHLW/PMDA and KOL for focused area (ex.
regenerative medical products, new regulation etc) Support internal functions through training on specific regulatory intelligence issues Qualifications REPORTING RELATIONSHIPS.
Japan Regulatory Affairs.
Director, Japan RA TA-Group Leader EDUCATION, EXPERIENCE & SKILL REQUIREMENTS.
Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline Minimum of 8 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/ PharmD and 6+ years, PhD and 4+ years Working knowledge of regulations in Japan and/or experience of regulatory in product approval and licensing.
Excellent working knowledge of the regional regulatory framework and how that applies to pharmaceutical product development.
Excellent verbal and written communications skills in Japanese and English Extensive experience in regulatory policy activities in industry or trade associations.
Experience in HAs interactions Highly developed network amongst local regulators and other key associations and organizations.
Knowledge of regulatory texts, legal texts and extensive experience of regulatory affairs.