Job Description & How to Apply Below
IQVIA is focused on using data and science to help healthcare clients find better solutions for their patients. Individuals joining us are assured of a rewarding career in Life Sciences Consulting, with opportunities to address diverse and challenging client problems, contribute to cross-geography engagements, interact with senior client leaders, and gain exposure to a multicultural and collaborative work environment.
About our team – Regulatory Science and Strategy (RSS)
The Regulatory Science and Strategy (RSS) group sits within IQVIA's Real World Solutions business and supports life sciences clients in using real world evidence (RWE) more widely and effectively for regulatory purposes. RSS sells and delivers as a unified team, partnering with clients on regulatory strategy, study design, and submission planning across drugs, biologics, and devices. Our work spans externally controlled trials, post-marketing requirements (PMRs/PMCs), post-authorization safety studies (PASS), drug utilization studies (DUS), and emerging regulatory technology.
We are strategic thinkers, deep subject matter experts, and creative at our core. We are collaborative, intellectually curious, and entrepreneurial.
About the role:
As a Principal (Director-level) within RSS, you will own delivery leadership, drive business development, and serve as a subject matter expert across two connected areas: selling and delivering standalone regulatory strategy engagements and cross-functional RWE studies for regulatory decision-making. Your work will focus primarily on several areas:
First, a Principal is expected to lead high-quality standalone regulatory strategy engagements, build trusted relationships with new and existing clients, and strengthen IQVIA's regulatory science and strategy capabilities.
Second, the Principal acts as a subject matter expert on the use of RWE across the regulatory lifecycle, partnering cross-functionally with IQVIA Real World Solutions teams to shape, sell, and deliver RWE studies from pre-submission strategy through approval and post-market commitments. An in-depth understanding of EMA expectations is essential, with the ability to translate those expectations into study designs and submission strategies that clients can act on.
Specifically, as a member of the RSS team, the Principal participates in regulatory strategy proposal development, advises on regulatory pathways, and supports cross-functional proposal strategy and delivery for externally controlled trials, PASS, DUS, Reg Tech advisory work, and broader RWE-for-regulatory engagements.
In addition we expect you to make a key Team and operational contributions to RSS, including mentorship and capability building amongst your junior colleagues
Responsibilities
Lead sell and delivery of standalone RSS regulatory strategy engagements, owning work streams end-to-end and supporting team members on complex programs.
Support cross-functional IQVIA Real World Solutions teams in selling and delivering RWE generation programs for regulatory audiences, including externally controlled trials, premarket uses of RWE, PASS, and PMR/PMC fulfilment.
Contribute to RSS regulatory intelligence activities, monitoring the external regulatory environment and surfacing emerging information relevant to IQVIA's offerings and clients.
Act as a day-to-day owner of the regulatory science element of client engagements, with responsibility for client satisfaction and delivery quality.
Advise on strategy and delivery plans for RSS services, with a focus on EMA RWE activities and lifecycle management, supported by working knowledge of FDA, MHRA, Health Canada, and PMDA.
Maintain working familiarity with the activities and outputs of EMA and their impact on global harmonization of RW efforts.
Identify follow-on work and new revenue opportunities with existing clients, and support business development efforts with new client organizations.
Collaborate across IQVIA when client requirements span regulatory affairs, clinical development, and real world insights.
Provide direction, advice, and intellectual leadership to delivery teams and clients.
Contribute high-level input to client reports and presentations, and deliver findings to clients directly.
Mentor and coach junior consultants, sharing subject matter expertise to build RSS capability.
Participate in annual performance review processes and in recruitment of new staff.
Skills and Experience
The successful candidate will have a track record of success across most of the following competencies:
Industry and regulatory expertise: Maintains a constant focus on regulators, industry, and client trends in life sciences. Applies this knowledge to active client engagements and to business development.
Real world data expertise: Ability to advise on the design of real world studies to meet regulatory requirements, including externally controlled trials, PASS, PMR fulfillment, etc.
Regulated medical product experience: Ability to speak with senior client…
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