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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory science and strategy, with a strong focus on evidence generation, regulatory intelligence, and the ability to synthesize complex scientific and regulatory information. Proficient in developing strategic recommendations and managing client engagements in a fast-paced, evolving environment.
Highest-signal resume keywords
Regulatory AffairsReal-World Evidence GenerationRegulatory IntelligenceAnalytical SkillsCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory PathwaysEvidence-Generation PrinciplesLiterature ReviewRegulatory Document AnalysisClinical Development
Soft Skills
Problem-Solving SkillsAttention to DetailCross-Functional Team CollaborationCuriosityAbility to Manage Multiple Priorities
Tools & Technologies
Microsoft PowerPointMicrosoft WordMicrosoft Excel
Industry Keywords
Regulatory SciencePublic HealthEpidemiologyBiomedical SciencesLife Sciences
About the role
Key responsibilities & impact- Support 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
- Review regulatory guidance, policies, public health authority communications, and scientific publications
- Assist in developing real-world evidence evidence-generation strategies
- Assess real-world data sources, patient registries, natural history studies, and external control strategies
- Contribute to regulatory intelligence deliverables on evolving expectations, precedents, and trends
- Synthesize scientific, clinical, and regulatory information into decision-oriented insights
- Support benchmarking, policy monitoring, and horizon scanning
- Analyze regulatory documents, advisory committee materials, approval packages, and guidance documents
- Develop PowerPoint presentations, reports, briefing materials, and strategic recommendations
- Support meeting preparation, note taking, action-item management, and project coordination
- Contribute to client-facing discussions and internal working sessions
- Support proposal development, opportunity assessments, thought leadership, conference presentations, publications, white papers, and marketing content
- Contribute to knowledge management, methodology development, and practice-wide initiatives focused on regulatory innovation, intelligence, and AI-enabled solutions
Requirements
What you’ll need- 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 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
Benefits
Comp & perks- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and welfare benefits may be offered
- Other benefits may be offered
