OverviewThe 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 FunctionsProject 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.
QualificationsRequired
- 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 ExpectationsAt 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.
The potential base pay range for this role, when annualized, is $58,700.00 - $146,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent 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.
