Associate Director, Regulatory Affairs (Oncology & Rare Disease) - Remote

Overview

The Associate Director of Regulatory Affairs will lead the regulatory strategy for Amgen's products in Japan, focusing on Oncology and Rare Disease, ensuring compliance with local regulations and facilitating patient access to innovative therapies.

In Short

• Lead regulatory strategy for Oncology and Rare Disease products in Japan.
• Ensure local labels comply with legislation and Amgen standards.
• Provide strategic regulatory guidance and manage key agency interactions.
• Supervise regulatory staff and support their professional development.
• Collaborate cross-functionally to align business and regulatory objectives.
• Monitor and communicate changes in local regulations and legislation.
• Engage with Health Authorities for product approval processes.
• Develop and implement compliance procedures for regulatory activities.
• Communicate effectively with stakeholders across the organization.
• Contribute to the development and execution of filing plans for Japan.

Requirements

• Doctorate degree with 11 years of relevant experience, or equivalent qualifications.
• Experience in Regulatory Affairs, particularly with PMDA/MHLW.
• Strong communication skills in Japanese and English.
• Ability to lead teams and manage multiple activities.
• Understanding of drug development and regulatory processes.
• Proven problem-solving abilities and action-oriented mindset.
• Experience in compliance and regulatory documentation.
• Ability to influence and engage with cross-functional teams.
• Experience in managing relationships with external vendors.
• Knowledge of Japan's medicinal product regulations.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and training.
• Flexible working arrangements.
• Access to cutting-edge research and technology.
• Supportive and collaborative work environment.
• Employee stock purchase plan.
• Generous paid time off and holidays.
• Retirement savings plan with company match.
• Commitment to diversity and inclusion in the workplace.