Regulatory Affairs Intelligence Director
Location: Hyderabad, India
Job ID: R-218756
Posted On: June 30, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a leading biotechnology company that leverages the power of science and technology to fight the world’s most serious illnesses. With more than four decades of innovation, Amgen focuses on four key therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—and is committed to improving lives worldwide.
About the Role:
The Regulatory Affairs Intelligence Director will lead the Global Regulatory Intelligence (GRI) function, playing a critical role in anticipating, interpreting, and integrating evolving global regulatory requirements into Amgen’s strategies and operations. This role directly impacts regulatory compliance, speed to market, and enterprise transformation through insightful intelligence and cross-functional leadership.
Key Responsibilities:
Leadership & Vision:
Define and execute the vision and operational strategy for the Global Regulatory Intelligence function.
Build the functional structure, staffing plans, and technology roadmap for intelligence gathering and utilization.
Strategic Regulatory Insight:
Identify and translate global regulatory trends into actionable internal guidance.
Serve as a senior regulatory advisor for enterprise-wide change planning in response to emerging regulatory frameworks.
Cross-Functional Integration:
Collaborate with Regulatory CMC, Safety, Clinical, and Policy teams to incorporate intelligence into regulatory submissions, labeling, and lifecycle strategies.
Drive enterprise transformation initiatives like structured submissions and digital regulatory requirements.
External Engagement:
Cultivate relationships with industry associations, regulatory authorities, and peer companies.
Represent Amgen in global forums and coordinate with Regulatory Policy and affiliates for proactive intelligence gathering.
Team Leadership & Development:
Build and mentor a high-performing team of regulatory intelligence professionals.
Oversee resource allocation, performance management, and vendor partnerships.
Operational Excellence:
Drive continuous improvement through innovation, data analytics, and automation tools to deliver efficient intelligence operations.
Required Knowledge and Skills:
Regulatory Expertise:
Deep understanding of global regulatory systems and high-impact changes.
Proven track record in assessing regulatory risks and shaping strategies accordingly.
Strategic Leadership:
Ability to align regulatory intelligence with broader business and development goals.
Competence in decision-making amid ambiguity and complexity.
External Communication:
Skilled in external representation with regulators and global partners.
Clear and effective communication tailored to various stakeholders including senior leadership.
Innovation & Systems Thinking:
Familiarity with modern digital tools, knowledge systems, and structured intelligence workflows.
Qualifications:
Doctorate degree with 4+ years of relevant experience
OR
Master’s degree with 15+ years of experience
OR
Bachelor’s degree with 16+ years of experience
Required Experience:
Leadership experience in regulatory intelligence, policy, or strategy
Demonstrated success in cross-functional regulatory programs and team development
Familiarity with regulatory intelligence platforms, data subscription tools, and industry benchmarking
Preferred Experience:
Background in building or expanding regulatory intelligence functions
Previous representation in global regulatory dialogues or initiatives
Estimated Salary: ₹75–95 LPA (based on leadership role and experience)
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