Overview
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.
Verantwortungsbereiche
- 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
Zentrale Anforderungen
- 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
Principal, Regulatory Science and Strategy - Real World Solutions Arbeitgeber: IQVIA
IQVIA ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in New Orleans die Möglichkeit bietet, in einem dynamischen und unterstützenden Umfeld zu arbeiten. Mit einem starken Fokus auf berufliche Weiterentwicklung und einem flexiblen Arbeitsmodell fördert das Unternehmen eine positive Work-Life-Balance und ermöglicht es den Flex Nurse Educators, Patienten durch innovative Bildungsansätze zu unterstützen. Die Unternehmenskultur legt Wert auf Teamarbeit und Vielfalt, was IQVIA zu einem attraktiven Arbeitsplatz für engagierte Fachkräfte macht.
