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
