Principal, Regulatory Science and Strategy - Real World Solutions

As a Principal in RSS, you drive delivery leadership and business development for regulatory strategy and RWE programs. You will serve as a subject-matter expert across standalone regulatory engagements and cross-functional RWE studies for regulatory decision-making, with a strong focus on EMA expectations. You’ll mentor teams, shape study designs and submission strategies, and strengthen client relationships. The role combines strategic advisory, project leadership, and cross-functional collaboration to advance regulatory science offerings. This is a high-impact role in a globally connected, entrepreneurial team.

• Lead end-to-end delivery and sales of standalone RSS regulatory strategy engagements
• Support cross-functional IQVIA Real World Solutions teams in selling/delivering RWE programs for regulatory audiences (externally controlled trials, premarket RWE, PASS, PMR/PMC)
• Contribute to RSS regulatory intelligence by monitoring external regulatory developments
• Own regulatory science components of client engagements, ensuring satisfaction and quality
• Advise on strategy and delivery plans for EMA RWE activities and lifecycle management with knowledge of FDA, MHRA, Health Canada, PMDA
• Maintain understanding of EMA activities and global harmonization impacts on RW efforts
• Identify follow-on work and new revenue opportunities with existing clients and assist in business development
• Collaborate across IQVIA on regulatory, clinical development, and RWE requirements
• Provide direction and intellectual leadership to delivery teams and clients
• Contribute to client reports/presentations and deliver findings directly to clients
• Mentor and coach junior consultants, contributing to RSS capability building
• Participate in performance reviews and recruitment of new staff

• 7+ years of professional experience in regulatory science/strategy or product review
• Strong academic background in life sciences; graduate degree preferred (PharmD, PhD, MD, MPH, MS)
• Experience with EMA or other health authorities is highly valued
• Experience in life sciences consulting or professional services preferred
• Proven track record of project leadership and people development
• Willingness to travel to client locations
• Fluency in English; right to work in the recruiting country

• Client relationship management
• Executive presence and clear communication
• Strategic thinking and problem solving
• Regulatory strategy design
• Real world evidence (RWE) study design
• Externally controlled trials