Senior Regulatory Affairs Associate – Regulatory Intelligence

Parexel

. Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies .

Posted 10/22/2026full-timeRemote • United States, CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory intelligence, compliance metrics analysis, and the application of global regulations in drug and device development. Proficient in utilizing AI-enabled platforms and collaborating with stakeholders to ensure adherence to regulatory standards.

Highest-signal resume keywords

Regulatory IntelligenceCompliance Metrics AnalysisFDA RegulationsMicrosoft Office SuiteClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Intelligence MonitoringImpact AssessmentGap AnalysisRegulatory Compliance ReportingProject CoordinationGxP KnowledgePharmacovigilanceDocument Management SystemsAI Taxonomy ManagementStakeholder Communication

Soft Skills

Interpersonal SkillsCritical ThinkingProblem-SolvingTeam CollaborationResults-Driven Approach

Tools & Technologies

AI-Enabled Regulatory Intelligence PlatformDocument Management SystemsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Regulatory AffairsDrug DevelopmentBiologic DevelopmentDevice DevelopmentGlobal Regulatory BodiesFDAEMAPMDAICHClinical Research

About the role

Key responsibilities & impact

Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies
Review regulatory content for relevance, distribute approved content to key stakeholders for impact assessment and gap analysis, and update stakeholder distribution lists
Collaborate with subject matter experts to assess implications of regulatory changes on products, development pipelines, and business operations
Track implementation of impact assessments and gap analyses with key stakeholders
Analyze and report impact assessment compliance metrics and follow up on risk-mitigation actions
Use the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content and update AI taxonomy terms
Participate in audits and inspections by supplying regulatory intelligence tracking and impact assessment evidence
Maintain familiarity with global standard operating procedures and working procedures in the document management system
Coordinate with Information Technology, Regulatory Technology, and the platform vendor on technical problems, access requests, and distribution issues
Stay current with regulatory intelligence trends and technologies and share learnings to improve compliance activities

Requirements

What you’ll need

Minimum of 2 years of work experience in regulatory intelligence
Bachelor's degree in a scientific or technical discipline
Previous experience analyzing and reporting compliance metrics
Solid working knowledge of drug, biologic, and device development processes, and of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH
Ability to plan, direct, organize, and coordinate projects
Excellent interpersonal skills, with strong written and verbal communication
Critical thinking and problem-solving skills
Results-driven, team-oriented collaborative approach
Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
Experience working in clinical research, healthcare, or a regulated environment
Comfort working with an AI-enabled regulatory intelligence platform, document management systems, and Microsoft Office
Preferred: Minimum of 2 years of regulatory affairs experience
Preferred: Previous interactions with the FDA or other health authorities
Preferred: Previous experience with pharmacovigilance or regulatory work in pharmacovigilance
Preferred: Previous experience developing newsletters

Benefits

Comp & perks

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs