Associate Consultant, Regulatory Science and Strategy

Falls Church, Virginia, United States of America

Durham, NC

Boston, MA

Wayne, PA, United States of America

New York, NY

Full time

The Regulatory Science & Strategy (RSS) team is a specialized regulatory consulting group that supports pharmaceutical, biotechnology, and medical device companies across the product lifecycle. The RSS team helps clients navigate complex regulatory challenges, develop evidence-generation strategies, engage health authorities, and evaluate innovative approaches including real-world evidence (RWE), regulatory intelligence, AI-enabled regulatory technologies, and novel development pathways.

The Associate Consultant plays a key supporting role in the delivery of strategic regulatory engagements. Working alongside senior RSS team members, epidemiologists, and former regulators, this individual contributes to regulatory research, landscape assessments, evidence-generation planning, client deliverables, and business development support activities.

• 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.

• 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.

• 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.

• 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.

At the Associate Consultant level, individuals are expected to:

• Build foundational expertise in regulatory science and…