Regulatory Affairs Senior Manager

Group Purpose

Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regulatory strategy.  The group also obtains and maintains local pharmaceutical company licenses and foreign manufacturing accreditation.

Job Summary

• The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen’s commercialization process; continuously improving business processes; and developing our talent.
• The Japan Regulatory Strategy Group Sr Mgr may be assigned to multiple Amgen products for product-specific activities.
• The Japan Regulatory Strategy Group Sr Mgr has high level English language skills, deep SME Japan regulatory requirements and strong interpersonal skills with ability to influence and engage.
• Work closely with Global Regulatory Lead to integrate Japan regulator strategy into Global regulatory strategy.

Key Activities

Strategy and Execution

• Develops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible.
• Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals.
• Proactively influence developing the global regulatory strategy so that Japan developments are aligned.
• Consistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients.
• As a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams.
• Leads or oversees the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan.
• Ensures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements.
• Ensures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures.
• Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen
• Lead process standardization/simplification to improve efficiency in regulatory processes
• Facilitate strategically using vendors.
• Consistently demonstrate Amgen leadership behaviors
• Influence developing global regulatory strategies so that Japan development strategies are aligned.
• Increase visibility of RA Japan.
• Provide strong supports to the Japan Regulatory Strategy Group Head.
• Provide strong supports to the Japan Regulatory Head

Communication and Collaboration

• Works cross-functionally with the various Amgen teams related to NDAs, PMDA consultations and CTNs, etc.
• Communicates clearly and in a timely manner with key stakeholders across the business.
• Provides subject matter expert support for local, regional, and global initiatives.

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.
• Attends HA meetings.
• Develops and maintain a good relationship with HAs in Japan to facilitate drug approvals.

External Interactions

• Engages with local trade associations to shape the external environment, monitors national legislation, and provides feedback to global and local colleagues in a timely manner.

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

• Ability to develop and lead effective teams
• Ability to work in matrix environments including cross-functional and global teams
• Ability to work under minimal direction with a medium degree of autonomy
• Analytical skills to evaluate and interpret complex situations and problems
• Ability to anticipate and prevent potential problems.
• Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives
• Understanding of regulatory activities and how they affect projects and processes
• Ability to understand and communicate scientific and clinical information
• Organizational, communication, and time management skills needed to manage multiple assignments and processes
• Communication skills in English (TOEIC score ≥860 desirable)
• Native level Japanese
• Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools

Education / Experience

Basic

• Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs

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