Director Regulatory Affairs

ure, and processes that enable sustainable success, cross-functional collaboration, and business agility.

Key Responsibilities

• People & Organizational Leadership
  • 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 to thrive within AIN and the broader Amgen organization.
  • Promote behaviors and ways of working consistent with Amgen's values and leadership attributes.
• Regulatory & Operational Accountability
  • 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 aligned with global business objectives.
• Strategic Alignment & Cross-Functional Collaboration
  • Build and maintain strong partnerships with global functional leaders and internal stakeholders to ensure effective coordination and alignment on business priorities.
  • Serve as a trusted and proactive cross-functional partner, fostering collaboration across disciplines, geographies, and business areas.
  • Lead department planning and performance monitoring; proactively identify and address emerging challenges and opportunities.
  • Serve as a key liaison between local AIN teams and global CMC & Device leadership, ensuring consistency in strategic direction and communication.
  • Represent the CMC & Device Regulatory AIN Team to Global Regulatory Affairs and Strategy Senior Leadership(s) as appropriate
• Culture, Compliance & Engagement

  • Promote a culture of inclusion, compliance, and accountability within AIN.

  • Champion Amgen's values by fostering an environment of respect, trust, and integrity.

Leadership Competencies & Attributes

• Emotional Intelligence: Leads with empathy, fosters psychological safety, and supports a positive team environment.

• Strategic Thinking: Connects regulatory and operational priorities to broader organizational goals.

• Communication: Communicates clearly, builds alignment, and encourages transparency across functions and geographies.

• Cross-Functional Partnership: Builds trust and collaboration across global and functional boundaries to achieve shared success.

• Coaching Mindset: Empowers team members through mentorship, feedback, and development opportunities.

• Adaptability: Demonstrates flexibility to accommodate competing needs and leads with resilience through change.

• Cultural Leadership: Promotes inclusion, respect, and values-driven decision-making.

Basic Qualifications

• Doctorate degree, 15+ years of experience in CMC and/or Device regulatory, and 8 years of leadership experience

• Master's degree and 17+ years of experience in CMC and/or Device regulatory, and 10 years of leadership experience

• Bachelor's degree, 20+ years of experience in CMC and/or Device regulatory, and 15 years of leadership experience

Preferred Qualifications

• 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

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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. Please contact us to request an accommodation.

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