Regulatory Strategy Associate — Evidence & RWE Consulting

IQVIA Inc; Boston (MA); On-site; USD 59,000 - 147,000; Full time

Job summary

IQVIA is seeking an Associate Consultant to support Regulatory Science & Strategy engagements across drugs, biologics, devices, and diagnostics. You will conduct literature reviews, landscape assessments, and develop evidence-generation plans in collaboration with senior team members and regulators.

The role emphasizes synthesizing complex scientific/regulatory information into concise insights, producing high-quality client deliverables, and contributing to business development and proposal

Qualifications

• Master's degree or equivalent in Regulatory Affairs, Epidemiology, Public Health, Health Outcomes Research, Pharmacy, Biomedical Sciences, Life Sciences, or related field.
• Bachelor's degree with demonstrated experience in regulatory affairs, consulting, evidence generation, life sciences research, or related fields.

Responsibilities

• 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.

Skills

Analytical ability

Regulatory research

Written communication

Cross-functional teamwork

Education

Master's degree in Regulatory Affairs / Regulatory Science

Bachelor's degree with regulatory experience

Tools

Regulatory databases

Microsoft Office

Regulatory intelligence tools

Job description

IQVIA is seeking an Associate Consultant to support Regulatory Science & Strategy engagements across drugs, biologics, devices, and diagnostics. You will conduct literature reviews, landscape assessments, and develop evidence-generation plans in collaboration with senior team members and regulators.

The role emphasizes synthesizing complex scientific/regulatory information into concise insights, producing high-quality client deliverables, and contributing to business development and proposal