Job Title:
Associate Director, Regulatory Affairs
Location:
India – Hyderabad
Job ID:
R-229125
Work Location Type:
On Site
Date Posted:
November 03, 2025
Job Category:
Regulatory Affairs
Position Overview
The Associate Director, Regulatory Affairs serves as 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 global sites and functional interfaces, ensuring that the AIN team delivers high-quality, compliant regulatory and operational outputs that support Amgen’s mission to serve patients.
The position demands a balance of strategic oversight and hands-on leadership to build systems, culture, and processes that foster collaboration, sustainability, and agility.
Key Responsibilities
1. People & Organizational Leadership
Provide inclusive, inspiring leadership to the CMC & Device Regulatory team in AIN.
Attract, hire, and retain top regulatory talent while promoting learning, inclusion, and performance.
Ensure staff receive proper onboarding, development, and mentorship.
Model behaviors aligned with Amgen’s values and leadership attributes.
2. Regulatory & Operational Accountability
Oversee regulatory work performed by AIN staff, including:
Global change assessments
State and federal licensure
Submission execution and periodic reporting
Process enhancements
Partner with global regulatory leadership to ensure strategic alignment across Amgen’s products.
Maintain high-quality, timely, and compliant deliverables aligned with global business goals.
3. Strategic Alignment & Cross-Functional Collaboration
Build and maintain strong partnerships with global functional leaders.
Act as a trusted, proactive partner across geographies and disciplines.
Lead departmental planning, performance tracking, and proactive risk mitigation.
Serve as the key liaison between AIN and global CMC & Device Regulatory leadership.
Represent the AIN team in Global Regulatory Affairs and Strategy Senior Leadership discussions.
4. Culture, Compliance & Engagement
Foster a culture of inclusion, compliance, and accountability within AIN.
Uphold Amgen’s values of respect, trust, and integrity.
Ensure adherence to all regulatory, ethical, and quality standards.
Leadership Competencies & Attributes
Emotional Intelligence: Leads with empathy and builds psychological safety.
Strategic Thinking: Connects regulatory activities to broader business goals.
Communication: Promotes transparency and alignment across functions.
Cross-Functional Partnership: Builds trust and collaboration globally.
Coaching Mindset: Develops team members through mentorship and feedback.
Adaptability: Responds flexibly to change and competing priorities.
Cultural Leadership: Fosters inclusion and values-driven decision-making.
Qualifications
Basic Qualifications
Doctorate degree with 5+ years of CMC/Device regulatory experience and 2+ years in leadership, OR
Master’s degree with 6+ years of CMC/Device regulatory experience and 4+ years in leadership, OR
Bachelor’s degree with 7+ years of CMC/Device regulatory experience and 6+ years in leadership.
Preferred Qualifications
Proven experience in CMC and/or Device Regulatory Affairs, including:
Change management
Strategy development across product modalities (including medical devices)
Global submission execution
Experience leading cross-functional or matrixed global teams.
Strong knowledge of regulatory operations, global HA requirements, and product lifecycle management.
Excellent communication, collaboration, and stakeholder engagement skills.
Ability to balance strategic priorities with hands-on operational delivery.
Experience with process improvement, digital transformation, or organizational change initiatives.
Demonstrated ability to maintain staff engagement while managing multiple priorities.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Amgen provides reasonable accommodations for individuals with disabilities to support application, interview, and employment processes.
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