Associate Vice President - Global Regulatory Affairs, Global Regulatory Policy & Strategy (Gene[...]

Company: Hispanic Alliance for Career Enhancement
Location: Indianapolis
Posted on: May 3, 2025

Job Description:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work worldwide to discover and deliver life-changing medicines, improve disease management, and support communities through philanthropy and volunteerism. We prioritize our work and put people first, seeking individuals committed to enhancing lives globally.
We serve an extraordinary purpose by developing medicines that enable longer, healthier, and more active lives. Beyond delivering breakthrough medications, we foster community support through innovative solutions and social responsibility.
Organization Overview:
Global Regulatory Policy & Strategy aims to enable Lilly to achieve innovative regulatory results by identifying policy challenges, developing science-based advocacy strategies, engaging partners, and influencing regulatory policies to improve patient outcomes, reduce risks, and enhance drug development efficiency. The Associate Vice President role in Global Regulatory Affairs (Genetic Medicine and Neuroscience) involves shaping Lilly's regulatory policy positions and advocacy strategies in these areas, representing Lilly in external forums, and leveraging a network of collaborators.
Responsibilities:

• Develop strategies and policy positions for genetic medicine and neuroscience projects impacting the business.
  
• Build consensus on global regulatory topics aligned with GRA's vision, focusing on innovation in drug development and review processes.
  
• Analyze regulatory and legislative proposals for potential impacts, collaborating with cross-functional teams.
  
• Define regulatory challenges and future goals clearly.
  
• Gather and develop data supporting company positions, working with colleagues.
  
• Represent external viewpoints in policy development.
  
• Foster relationships with internal subject matter experts and external partners to develop evidence-based policies.
  
• Implement tactical advocacy plans.
  
• Influence GRA and broader Lilly initiatives.
  
  External Influence:
  
  
• Build strategic relationships with regulators and external stakeholders.
  
• Monitor external environment changes and develop response plans.
  
• Participate in health policy forums and industry conferences.
  
• Maintain collaborations with patient groups, think tanks, and policy organizations.
  
• Drive patient outcomes through external partnerships.
  
  Leadership and Collaboration:
  
  
• Model Lilly's core behaviors: Include, Innovate, Accelerate, Deliver.
  
• Lead forums for regulatory knowledge sharing.
  
• Create an environment fostering open discussion and robust decision-making.
  
• Make strategic decisions influencing business direction.
  
• Influence senior leaders, regulators, and partners on critical issues.
  
• Lead complex problem resolution with critical thinking.
  
  Qualifications:
  

• 
  
• Master's or Doctorate Degree with 10+ years of relevant experience in research, regulation, policy, or advocacy.
  
  Preferred Skills:
  
  • 
    
  • Recognized as an external thought leader in regulatory policy.
    
  • Strong external network in regulatory policy.
    
  • Experience in external consortia and policy campaigns.
    
  • Background in genetic medicine or neuroscience policy issues.
    
  • Experience with FDA, BIO, and related organizations.
    
  • Proficient in high-level communications and influencing without authority.
    
    Additional Information:
    
    • 
      
    • Travel up to 20%.
      
    • Location options: Indianapolis, IN; Washington, DC; Boston, MA; Remote.
      
    • Salary range: $238,500 - $349,800, plus bonuses and benefits.
      
      Lilly is committed to diversity and inclusion and offers accommodations for applicants with disabilities. We are an EEO employer. Learn more about our Employee Resource Groups and benefits.
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