Associate Consultant, Regulatory Science and Strategy

Overview

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.

Essential Functions

Project Delivery

• 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.

Analysis & Insights

• 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.

Client Deliverables

• 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.

Business & Practice Support

• 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.

Qualifications

Required

• 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.

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.

Knowledge, Skills, and Abilities

• 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.

Career Progression Expectations

At the Associate Consultant level, individuals are expected to:

• Build foundational expertise in regulatory science and strategy.
• Independently execute defined workstreams with limited oversight.
• Develop client-facing consulting skills.
• Contribute to thought leadership and knowledge development activities.
• Progress toward ownership of increasingly complex project tasks and client interactions.

This role serves as a foundational consulting position within RSS and provides exposure to innovative regulatory challenges across the product lifecycle, including regulatory strategy, regulatory intelligence, regulator interactions, real-world evidence, and emerging regulatory technologies.

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