Associate Director – Regulatory Affairs
Location: Hyderabad, India
Category: Regulatory
Work Type: On-Site
Job ID: R-229125
Amgen is seeking an experienced Associate Director, Regulatory Affairs, to lead the CMC & Device Regulatory function within Amgen India (AIN). This senior leadership role is responsible for operational excellence, team development, regulatory strategy execution, and alignment with global regulatory priorities. The ideal candidate will bring strong expertise in CMC and/or Device regulatory affairs, proven leadership experience, and the ability to collaborate across global teams.
Role Overview
The Associate Director will manage a diverse team accountable for regulatory and operational deliverables, including global change assessments, medical device regulatory strategy, submission planning, and execution across product lifecycles. This position requires a strategic mindset coupled with hands-on leadership to strengthen systems, processes, and cross-functional engagement.
Key Responsibilities
1. People & Organizational Leadership
Provide inclusive leadership for the CMC & Device Regulatory team in AIN.
Attract, hire, mentor, and retain high-performing regulatory professionals.
Support onboarding, capability development, and career growth.
Promote a culture of learning, integrity, inclusion, and continuous improvement.
2. Regulatory & Operational Accountability
Oversee regulatory deliverables including global change assessments, licensure, submission execution, periodic reporting, and process optimization.
Ensure compliance with global health authority requirements and internal quality standards.
Partner with global regulatory leaders to ensure alignment with product and business priorities.
3. Strategic Alignment & Cross-Functional Collaboration
Build strong partnerships with global functional and regulatory stakeholders.
Lead planning activities, performance monitoring, and risk mitigation.
Serve as the key connection between AIN teams and global CMC & Device leadership.
Facilitate smooth cross-functional collaboration across disciplines and geographies.
4. Culture, Compliance & Engagement
Champion Amgen’s values of respect, trust, integrity, and inclusion.
Ensure a culture of compliance and accountability within the regulatory function.
Drive initiatives that strengthen engagement and operational excellence.
Leadership Competencies
Emotional Intelligence: Supports psychological safety and team well-being.
Strategic Thinking: Aligns regulatory priorities with organizational goals.
Communication: Ensures clarity and alignment across teams.
Cross-Functional Partnership: Builds strong, trust-based relationships globally.
Coaching Mindset: Enables employee development through feedback and mentoring.
Adaptability: Leads with resilience in dynamic regulatory environments.
Cultural Leadership: Promotes inclusive and values-driven decision-making.
Required Experience & Qualifications
You must meet one of the following:
Doctorate degree with 5+ years of experience in CMC and/or Device Regulatory Affairs and 2+ years of leadership experience
Master’s degree with 6+ years of CMC and/or Device Regulatory experience and 4+ years of leadership experience
Bachelor’s degree with 7+ years of CMC and/or Device Regulatory experience and 6+ years of leadership experience
Preferred Qualifications
Extensive experience in CMC or Device regulatory affairs, including change management, multi-modality strategy development, and global submission execution.
Strong understanding of global regulatory operations and lifecycle management.
Proven success leading global, cross-functional, or matrixed teams.
Excellent communication, stakeholder management, and collaboration skills.
Experience driving digital transformation, process improvements, or organizational change initiatives.
Ability to manage competing priorities while maintaining strong team engagement.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer and evaluates applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations will be provided throughout the application and employment processes upon request.
Apply Now
Advance your leadership career in global regulatory affairs and contribute to Amgen’s mission of delivering innovative therapies to patients worldwide.
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