Associate Consultant, Regulatory Science and Strategy

IQVIA is hiring an Associate Consultant to support regulatory science and strategy consulting engagements for pharmaceutical, biotechnology, and medical device clients. The role contributes regulatory research, evidence-generation planning, regulatory intelligence, client deliverables, and business development support across the product lifecycle.

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
• Synthesize scientific, clinical, and regulatory information into concise, decision-oriented insights
• Support benchmarking activities across products, therapeutic areas, and regulatory jurisdictions
• Assist with policy monitoring and horizon scanning activities
• Analyze publicly available regulatory documents, advisory committee materials, approval packages, and guidance documents
• 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
• Support proposal development, opportunity assessments, and thought leadership initiatives
• Assist with preparation of conference presentations, publications, white papers, and marketing content
• Contribute to internal knowledge management activities and methodology development
• Participate in practice-wide initiatives focused on regulatory innovation, regulatory intelligence, and AI-enabled solutions

Preferred

• Experience interpreting regulatory authority guidance
• Knowledge of clinical development, regulatory pathways, and evidence-generation principles
• Exposure to regulatory intelligence, real-world evidence, epidemiology, or medical writing
• Familiarity with emerging topics such as artificial intelligence in healthcare, rare disease development, digital twins, and external controls
• Regulatory Guidance Interpretation
• Clinical Development
• Regulatory Pathways
• Regulatory Intelligence
• Real-World Evidence
• Medical Writing
• Healthcare AI
• Rare Disease Development
• Digital Twins
• External Controls

Benefits

• Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Company

• Clinical research, commercial insights, and healthcare intelligence for life sciences.
• Durham, North Carolina, USA
• https://www.iqvia.com/
• Founded in 1982
• 10001+ employees

Qualifications

• 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
• Strong analytical and problem-solving skills
• Ability to synthesize complex scientific and regulatory information
• Excellent written and verbal communication skills
• Strong attention to detail and commitment to quality
• Ability to work effectively within cross-functional teams
• Ability to manage multiple priorities and deadlines simultaneously
• Proficiency in Microsoft PowerPoint, Word, and Excel
• Curiosity and willingness to learn in fast-paced, evolving scientific and regulatory environments
• Comfort working in ambiguity and supporting innovative client challenges
• Experience interpreting regulatory authority guidance
• Knowledge of clinical development, regulatory pathways, and evidence-generation principles
• Exposure to regulatory intelligence, real-world evidence, epidemiology, or medical writing
• Familiarity with emerging topics such as artificial intelligence in healthcare, rare disease development, digital twins, and external controls

Required skills

• Clinical Development, Epidemiology, Evidence Generation, Medical Writing, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Real-World Evidence, Regulatory Guidance Interpretation, Regulatory Intelligence, Regulatory Pathways

Preferred skills

• Experience interpreting regulatory authority guidance

Experience

• Entry level