Associate Director Regulatory Affairs

Career CategoryRegulatoryJob DescriptionWhat you will doThe Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's 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 Amgen's mission to serve patients.The Associate Director will lead a diverse team accountable for regulatory and operational deliverables—including 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 leadership—building systems, culture, and processes that enable sustainable success, cross-functional collaboration, and business agility. Key ResponsibilitiesPeople & Organizational LeadershipProvide 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 AccountabilityOversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancementsPartner 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 CollaborationBuild 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 appropriateCulture, Compliance & EngagementPromote a culture of inclusion, compliance, and accountability within AIN.Champion Amgen's values by fostering an environment of respect, trust, and integrity. Leadership Competencies & AttributesEmotional 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 QualificationsDoctorate degree, 5 years of experience in CMC and/or Device regulatory, and 2 years of leadership experienceMaster's degree and 6 years of experience in CMC and/or Device regulatory, and 4 years of leadership experienceBachelor's degree, 7 years of experience in CMC and/or Device regulatory, and 6 years of leadership experiencePreferred QualificationsProven experience in CMC and/or Device regulatory affairs, including change management, strategy development across modalities (including medical devices), and global submission executionDemonstrated success leading cross-functional or matrixed global teamsStrong understanding of regulatory operations, global health authority requirements, and product lifecycle managementExceptional communication, collaboration, and stakeholder engagement skillsAbility to balance strategic priorities with operational executionExperience driving process improvements, digital enablement, or organizational change initiativesFlexibility and judgment in managing competing priorities while maintaining strong staff engagementEQUAL 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. .