IQVIA Inc is seeking a Regulatory Strategy Lead to provide senior regulatory and project leadership for global drug development projects. The ideal candidate will have extensive regulatory experience in both the US and EU, overseeing key regulatory submissions and leading cross-functional teams
Job Summary
Provides senior regulatory and integrated project leadership for global drug development projects, with deep hands-on expertise in US and EU regulatory strategy and delivery.
Acts as both Regulatory Lead and Project Lead, with direct accountability for authoring and delivering key regulatory submissions and leading cross-functional development activities.
Working directly with biopharmaceutical clients, this role serves as a trusted strategic advisor and primary point of contact, integrating regulatory, clinical, safety, CMC, nonclinical, biostatistical, and commercial inputs.
Matching Summary
Match Score: 85
IQVIA Inc is seeking a Regulatory Strategy Lead to provide senior regulatory and project leadership for global drug development projects. The ideal candidate will have extensive regulatory experience in both the US and EU, overseeing key regulatory submissions and leading cross-functional teams.
Skills & Requirements
Must-have
US and EU regulatory strategy
Global drug development projects
Regulatory submissions authoring and delivery
Cross-functional development strategy
Client advisory and communication
Nice-to-have
Mentoring junior colleagues
Business development contributions
Resilience in high-pressure environments
Key Requirements
Master’s degree in Life Sciences or related discipline
8+ years of relevant experience
Significant hands-on US and EU/UK regulatory experience
Experience leading and authoring major regulatory deliverables
Experience leading matrixed, multidisciplinary teams