Associate Director, Regulatory Affairs (Oncology & Rare Disease)

<h2><b>Career Category</b></h2>Regulatory<h2></h2><h2><b>Job Description</b></h2><p><b>Corporate Title</b></p><p>Regulatory Affairs Assoc. Director</p><p><b>Title (Role)</b></p><p>Head of Japan Regulatory Strategy for Oncology and Rare Disease</p><p><b>Specialty</b></p><p>Regulatory Affairs</p><p><b>Team</b></p><p>Local Regulatory Affairs (Japan)</p><p><b>Function</b></p><p>Global Regulatory Affairs and Strategy (GRAAS), R&amp;D</p><p><b>Group Purpose</b></p><p>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.</p><p><b>Job Summary</b></p><p><b>Responsible for:</b></p><ul><li>Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions</li><li>Ensures local labels are developed and maintained in line with local legislation and Amgen standards and procedures</li><li>Supervisory oversight for multiple regulatory staff</li><li>Be a key point of contact for Japan Regulatory</li><li>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</li></ul><p><b>Key Activities</b></p><p><b>Strategy and Execution</b></p><ul><li>Senior contact point for regulatory advice for commercial and medical projects for Japan</li><li>Translates global and international business plans to local regulatory</li><li>Represents Regulatory on Japan affiliate</li><li>Contributes to and execute filing plan for Japan</li><li>Develops local expertise to evaluate and achieve regulatory success based on proposed strategies</li><li>Supports the monitoring, auditing and self-assessment activities under the compliance framework</li><li>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</li></ul><p></p><p><b>Communication and Collaboration</b></p><ul><li>Works cross-functionally with the various Amgen teams related to JNDAs, PMDA consultations and CTNs, etc.</li><li>Ensures to develop, implement and maintain processes and procedures to meet local regulatory procedures</li><li>Ensures awareness of and adherence to defined communication pathways for relevant functions</li><li>Exchanges regulatory information with other regulatory colleagues on an ongoing basis and provide advice on regional regulatory considerations in a timely manner</li><li>Communicates and ensures alignment of functional and cross functional goals and objectives</li><li>Works closely with cross-functional, local, regional and global colleagues to deliver Amgen goals in accordance with Japan regulatory requirements</li><li>Partners with GRA colleagues to support development, registration, and lifecycle management for Amgen products</li><li>Communicates clearly and in a timely fashion with key stakeholders across the business</li></ul><p></p><p><b>External Interactions</b></p><ul><li>Manages Functional Service Providers (FSP) vendors: due diligence and ongoing relationship as required</li><li>Monitors changes in local trade association, code and national legislation and communicate information to local /regional/regulatory Intelligence groups and feedback into strategy</li><li>Leads/attends Health Authority interactions and meetings as required</li><li>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</li></ul><p></p><p><b>Health Authority (HA) Interaction</b></p><ul><li>Acts as the primary interface with MHLW and PMDA for product approval and clinical development.</li><li>Leads and contributes to strategy for HA interactions for Japan.</li><li>Attends and leads HA meetings.</li><li>Develops and maintain a good relationship with MHLW and PMDA</li><li>Participates in local industry and trade association</li></ul><p></p><p><b>Strategy and Execution</b></p><ul><li>Is the senior contact point for regulatory advice on commercial and medical projects </li><li>Represents Regulatory on relevant national &amp; sub-regional management teams</li><li>Develops regional expertise to evaluate and achieve regulatory success based on proposed strategies</li><li>Contributes to and execute filing plan for Japan</li><li>Translates global and international business plans to local regulatory objectives</li><li>Monitors external regulatory environment to inform regulatory decision making</li></ul><p></p><p><b>Compliance</b></p><ul><li>Maintains regulatory compliance for all documents submitted to HA and post-approval commitments.</li><li>Supports the monitoring, auditing, and self-assessment activities under the compliance framework.</li><li>Contributes to the development and implementation of country-specific compliance procedures and working practices.</li></ul><p><b>Knowledge and Skills</b></p><ul><li>Experience working with PMDA/MHLW, CROs, and/or contractors</li><li>Ability to lead teams</li><li>Strong communication skills - both oral and written in Japanese and in English (TOEIC score ≥860 desirable)</li><li>Ability to understand and communicate scientific/clinical information</li><li>Understanding of regulatory activities and how they affect projects and processes</li><li>Ability to set organizational direction &amp; champion change and continuous improvement</li><li>Ability to anticipate and mitigate future strategic issues &amp; uncertainties</li><li>Ability to resolve conflicts and develop a course of action leading to a beneficial outcome</li></ul><p></p><p>Competencies</p><ul><li>Planning and organizing abilities</li><li>Managing multiple activities</li><li>Problem solving abilities</li><li>Setting priorities</li><li>Action orientated</li><li>Building effective teams</li><li>Presentation Skills</li><li>Written Communications</li></ul><p><b>Education / Experience</b></p><p><b>Basic</b></p><p>Doctorate degree and 11 years of directly related experience including 6&#43; years of experience in Regulatory Affairs</p><p>OR</p><p>Master’s degree and 13 years of directly related experience including 8&#43; years of experience in Regulatory Affairs</p><p>OR</p><p>Bachelor’s degree and 15 years of directly related experience including 10&#43; years of experience in Regulatory Affairs</p><p>AND</p><p>4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources</p><p><b>Education / Experience</b></p><p><b>Preferred</b></p><ul><li>Advanced degree preferred</li><li>In-depth regulatory experience</li><li>Knowledge of Japan legislation and regulations relating to medicinal products</li><li>Knowledge of drug development Scientific/Technical Excellence</li><li>Teamwork</li><li>Communication skills both oral and written</li><li>Ability to understand and communicate scientific/clinical information</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.