Description
**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
