**Corporate Title** Regulatory Affairs Assoc. Director **Title (Role)** Head of Japan Regulatory Strategy for Oncology and Rare Disease **Specialty** Regulatory Affairs **Team** Local Regulatory Affairs (Japan) **Function** Global Regulatory Affairs and Strategy (GRAAS), R&D **Group Purpose** Facilitate patient access to Amgen products in Japan through executing on our filing plans; providing strategic regulatory guidance on Japan regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating Amgen’s commercialization process, and continuously improving our processes and developing our talent. **Job Summary** **Responsible for:** + Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions + Ensures local labels are developed and maintained in line with local legislation and Amgen standards and procedures + Supervisory oversight for multiple regulatory staff + Be a key point of contact for Japan Regulatory + The Japan Regulatory Strategy Group Head has high level English language skills, deep SME Japan regulatory requirements and strong interpersonal skills with ability to influence and engage **Key Activities** **Strategy and Execution** + Senior contact point for regulatory advice for commercial and medical projects for Japan + Translates global and international business plans to local regulatory + Represents Regulatory on Japan affiliate + Contributes to and execute filing plan for Japan + Develops local expertise to evaluate and achieve regulatory success based on proposed strategies + Supports the monitoring, auditing and self-assessment activities under the compliance framework + Monitors changes in local trade Association, Code and national legislation and forward information to local /regional/reg intel groups and feedback into strategy in a timely manner **Communication and Collaboration** + Works cross-functionally with the various Amgen teams related to JNDAs, PMDA consultations and CTNs, etc. + Ensures to develop, implement and maintain processes and procedures to meet local regulatory procedures + Ensures awareness of and adherence to defined communication pathways for relevant functions + Exchanges regulatory information with other regulatory colleagues on an ongoing basis and provide advice on regional regulatory considerations in a timely manner + Communicates and ensures alignment of functional and cross functional goals and objectives + Works closely with cross-functional, local, regional and global colleagues to deliver Amgen goals in accordance with Japan regulatory requirements + Partners with GRA colleagues to support development, registration, and lifecycle management for Amgen products + Communicates clearly and in a timely fashion with key stakeholders across the business **External Interactions** + Manages Functional Service Providers (FSP) vendors: due diligence and ongoing relationship as required + Monitors changes in local trade association, code and national legislation and communicate information to local /regional/regulatory Intelligence groups and feedback into strategy + Leads/attends Health Authority interactions and meetings as required + Engages with local trade Associations to shape the external environment, monitors national legislation and provides feedback to regional and global colleagues in a timely manner **Health Authority (HA) Interaction** + Acts as the primary interface with MHLW and PMDA for product approval and clinical development. + Leads and contributes to strategy for HA interactions for Japan. + Attends and leads HA meetings. + Develops and maintain a good relationship with MHLW and PMDA + Participates in local industry and trade association **Strategy and Execution** + Is the senior contact point for regulatory advice on commercial and medical projects + Represents Regulatory on relevant national & sub-regional management teams + Develops regional expertise to evaluate and achieve regulatory success based on proposed strategies + Contributes to and execute filing plan for Japan + Translates global and international business plans to local regulatory objectives + Monitors external regulatory environment to inform regulatory decision making **Compliance** + Maintains regulatory compliance for all documents submitted to HA and post-approval commitments. + Supports the monitoring, auditing, and self-assessment activities under the compliance framework. + Contributes to the development and implementation of country-specific compliance procedures and working practices. **Knowledge and Skills** + Experience working with PMDA/MHLW, CROs, and/or contractors + Ability to lead teams + Strong communication skills - both oral and written in Japanese and in English (TOEIC score ≥860 desirable) + Ability to understand and communicate scientific/clinical information + Understanding of regulatory activities and how they affect projects and processes + Ability to set organizational direction & champion change and continuous improvement + Ability to anticipate and mitigate future strategic issues & uncertainties + Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Competencies + Planning and organizing abilities + Managing multiple activities + Problem solving abilities + Setting priorities + Action orientated + Building effective teams + Presentation Skills + Written Communications **Education / Experience** **Basic** Doctorate degree and 11 years of directly related experience including 6+ years of experience in Regulatory Affairs OR Master’s degree and 13 years of directly related experience including 8+ years of experience in Regulatory Affairs OR Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources **Education / Experience** **Preferred** + Advanced degree preferred + In-depth regulatory experience + Knowledge of Japan legislation and regulations relating to medicinal products + Knowledge of drug development Scientific/Technical Excellence + Teamwork + Communication skills both oral and written + Ability to understand and communicate scientific/clinical information