Associate Director, Regulatory Affairs (Oncology & Rare Disease)

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