Associate Director Regulatory Affairs

• Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
• Attract, hire, develop, and retain top regulatory talent
• foster a culture of learning, engagement, inclusion, and high performance
• Ensure staff receive appropriate onboarding, development, and ongoing support
• Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
• Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
• Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
• Ensure high-quality, timely, and compliant regulatory deliverables
• Build and maintain strong partnerships with global functional leaders and internal stakeholders
• Serve as a trusted and proactive cross-functional partner
• Lead department planning and performance monitoring
• Serve as a key liaison between local AIN teams and global CMC & Device leadership
• Represent the CMC & Device Regulatory AIN Team to Global Regulatory Affairs and Strategy Senior Leadership(s) as appropriate
• Promote a culture of inclusion, compliance, and accountability within AIN
• Champion Amgen’s values by fostering an environment of respect, trust, and integrity

• Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
• Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
• Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

• Proven experience in CMC and/or Device regulatory affairs, including change management, strategy development across modalities (including medical devices), and global submission execution
• Demonstrated success leading cross-functional or matrixed global teams
• Strong understanding of regulatory operations, global health authority requirements, and product lifecycle management
• Exceptional communication, collaboration, and stakeholder engagement skills
• Ability to balance strategic priorities with operational execution
• Experience driving process improvements, digital enablement, or organizational change initiatives
• Flexibility and judgment in managing competing priorities while maintaining strong staff engagement

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment