Not specified (potentially hybrid or flexible as per common industry practices).
15+ years cmc regulatory experience
8+ years leadership experience
Global submission execution expertise
Amgen UK is seeking a Director of Regulatory Affairs in India to lead their CMC & Device Regulatory Team. The role emphasizes strategic leadership, operational effectiveness, and fostering a culture of inclusion and high performance to ensure the successful delivery of regulatory and operational objectives
Job Summary
The Director provides senior leadership for the operational effectiveness and strategic alignment of Amgen's CMC & Device Regulatory Team in India.
This role is accountable for overseeing global change assessments, licensure, submission execution, and periodic reporting to ensure high-quality deliverables.
The position requires fostering a culture of inclusion, compliance, and accountability while partnering with global functional leaders to drive business priorities.
Matching Summary
Match Score: 85
Amgen UK is seeking a Director of Regulatory Affairs in India to lead their CMC & Device Regulatory Team. The role emphasizes strategic leadership, operational effectiveness, and fostering a culture of inclusion and high performance to ensure the successful delivery of regulatory and operational objectives.
Skills & Requirements
Must-have
15+ years CMC regulatory experience
8+ years leadership experience
Global submission execution expertise
Change assessment and strategy development
Medical device regulatory knowledge
Nice-to-have
Cross-functional global team leadership
Process improvement and digital enablement
Strong emotional intelligence and coaching
Inclusive culture building skills
Strategic alignment with business goals
Key Requirements
Doctorate degree with 15+ years experience
Master's degree with 17+ years experience
Bachelor's degree with 20+ years experience
Minimum 8 years of leadership experience
Proven track record in CMC and Device regulatory affairs