Regulatory Strategy Associate Consultant

IQVIA; Durham (NC); Presencial; USD 59.000 - 147.000; Jornada completa

Descripción de la vacante

IQVIA in Durham, NC, seeks an Associate Consultant to support Regulatory Science & Strategy engagements across drugs, biologics, medical devices, and diagnostics. You will conduct literature reviews, landscape assessments, and develop evidence-generation plans under guidance from senior team members.

You will help prepare client deliverables, support regulatory intelligence efforts, and contribute to business development activities.

Formación

• Master’s degree or equivalent advanced degree in Regulatory Affairs or Regulatory Science, Epidemiology, Public Health, Health Outcomes Research, Pharmacy, Biomedical Sciences, Life Sciences, or a related discipline; OR
• Bachelor’s degree with demonstrated experience in regulatory affairs, consulting, evidence generation, life sciences research, or related fields.

Responsabilidades

• Support the execution of regulatory science and strategy consulting engagements across drugs, biologics, medical devices, diagnostics, and combination products.
• Perform literature reviews, regulatory precedent analyses, and landscape assessments across global regulatory agencies.
• Conduct reviews of regulatory guidance, policies, public health authority communications, and scientific publications to support client objectives.
• Assist in the development of evidence-generation strategies involving RWE.
• Support assessments of real-world data sources, patient registries, natural history studies, and external control strategies.
• Contribute to regulatory intelligence deliverables that summarize evolving regulatory expectations, precedents, and emerging trends.
• Develop high-quality PowerPoint presentations, reports, briefing materials, and strategic recommendations.
• Support meeting preparation, note taking, action-item management, and project coordination activities.
• Contribute to client-facing discussions and internal working sessions.
• Ensure deliverables meet quality, scientific, and regulatory standards.

Conocimientos

Analytical skills

Regulatory knowledge

Communication skills

Cross-functional teamwork

Attention to detail

Microsoft Office

Educación

Master’s degree or equivalent

Bachelor’s degree with relevant experience

Herramientas

PowerPoint

Word

Excel

Descripción del empleo

IQVIA in Durham, NC, seeks an Associate Consultant to support Regulatory Science & Strategy engagements across drugs, biologics, medical devices, and diagnostics. You will conduct literature reviews, landscape assessments, and develop evidence-generation plans under guidance from senior team members.

You will help prepare client deliverables, support regulatory intelligence efforts, and contribute to business development activities.