Associate Director Regulatory Affairs

What you will do

The Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgens CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN staff are supported, connected, and empowered to deliver high-quality regulatory and operational work that advances Amgens mission to serve patients.

The Associate Director will lead a diverse team accountable for regulatory and operational deliverablesincluding change assessment, regulatory strategy across phases of development and modalities (including medical devices), and global submission execution.

This position requires a balance of strategic oversight and hands-on leadershipbuilding systems, culture, 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 Amgens 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 Amgens 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 Amgens 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, 5 years of experience in CMC and/or Device regulatory, and 2 years of leadership experience
• Masters degree and 6 years of experience in CMC and/or Device regulatory, and 4 years of leadership experience
• Bachelors degree, 7 years of experience in CMC and/or Device regulatory, and 6 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