Regulatory Affairs Intelligence Assoc Dir

Director, Global Regulatory Intelligence Team

The Director leads the strategic development and execution of the Global Regulatory Intelligence (GRI) function, ensuring Amgen stays ahead of an evolving global regulatory landscape. This role defines the team's mission, sets priorities, leads cross-functional collaborations, and ensures high-impact intelligence is embedded into regulatory strategy across the enterprise.

Key Responsibilities:

• Function Leadership & Vision:
  Establish and evolve the Regulatory Intelligence function, defining structure, staffing strategy, vendor/outsourcing model, and the technology roadmap to support global operations. Set the vision and oversee the execution of intelligence deliverables that enable accelerated, compliant global product filings and approvals.

• Strategic Regulatory Insight & Change Leadership:
  Lead development of strategic insights into global regulatory trends and changes. Translate intelligence into actionable internal guidance, influencing filing strategies, development plans, and Amgen’s engagement with evolving regulatory expectations. Serve as senior advisor on emerging regulatory shifts, coordinating enterprise-level change response strategies.

• External Engagement:
  Build and maintain relationships with external regulatory intelligence networks, peer companies, industry associations, and regulatory agencies to enhance Amgen’s proactive intelligence-gathering capabilities. Coordinate with Regulatory Policy and country affiliates to ensure early awareness of critical developments.

• Cross-Functional Integration:
  Partner with Global Regulatory Affairs, Regulatory CMC, Clinical, Safety, and Policy functions to integrate intelligence into product strategy, labeling, and lifecycle plans. Lead cross-functional initiatives where regulatory intelligence enables enterprise transformation (e.g., structured submissions, digital requirements).

• Team Management & Talent Development:
  Hire, develop, and lead a high-performing Regulatory Intelligence team (including direct reports and external partners). Set goals, manage performance, mentor staff, and build capabilities aligned with future-state regulatory operations. Define and oversee budget, resource allocation, and vendor management for the function.

• Operational Excellence & Innovation:
  Ensure efficient, scalable, and continuously improving intelligence operations. Drive the adoption of innovative tools, data analytics, and automation solutions to accelerate and enhance regulatory intelligence outputs.

Knowledge & Skills:

• Regulatory Expertise:
  Deep knowledge of global regulatory systems and evolving frameworks across major and emerging markets. Experience identifying and interpreting high-impact regulatory changes and their implications for development, submission, and approval strategies.

• Strategic & Analytical Thinking:
  Demonstrated ability to connect regulatory developments with strategic business impacts. Able to assess ambiguity, provide direction under uncertainty, and influence cross-functional decisions.

• External Presence & Influence:
  Skilled in representing Amgen in industry forums and engaging with regulatory bodies. Able to distill complex global issues into clear, compelling messaging for senior stakeholders.

• Leadership & Communication:
  Proven leadership of cross-functional teams and direct staff. Strong ability to communicate complex regulatory concepts clearly and persuasively across senior, technical, and global audiences.

• Innovation & Operational Mindset:
  Experience with process optimization, digital tools, and knowledge management systems. Ability to modernize intelligence workflows using structured data and automation.

Qualifications:

• Education:
  Doctorate degree and 4+ years of experience, or Master’s degree and 15+ years, or Bachelor’s degree and 16+ years in regulatory affairs, policy, intelligence, or a related field.

• Experience:

• Prior leadership experience in global regulatory intelligence, regulatory policy, or strategy.

• Strong track record of advising on and responding to regulatory change.

• Experience in leading cross-functional regulatory initiatives and managing high-performing teams.

• Familiarity with regulatory intelligence tools, subscription databases, and external benchmarking approaches.

• Preferred:

• Demonstrated success building or scaling regulatory intelligence capabilities.

• Experience interacting with global regulatory authorities and representing company positions externally.