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Parexel

Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

Parexel

Global Regulatory Labeling Lead providing strategic oversight for complex labeling initiatives. Collaborating on regulatory compliance across global markets to ensure safe product use.

Posted 7/6/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in global labeling strategy and regulatory compliance, with a strong focus on managing core labeling documents and leading cross-functional teams. Proficient in navigating complex regulatory environments and ensuring alignment across diverse markets.

Highest-signal resume keywords
Global Labeling StrategyRegulatory Labeling Lifecycle ManagementCross-Functional Team LeadershipRIMS Experience (e.g., Veeva RIMS)Fluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Core Data Sheet (CDS) ManagementUSPI CreationEU SmPC DevelopmentGlobal Patient Leaflet PreparationLabeling Content InterpretationCompliance ReviewHealth Authority NegotiationsDirect-to-Consumer Advertising ReviewSocial Media Content ComplianceArtwork Coordination
Soft Skills
Stakeholder InfluenceCultural SensitivityDecision-MakingTraining and Development
Tools & Technologies
VeevaDocubridgeTrackwiseMicrosoft OfficeSharePointAdobe AcrobatTVTPromomatsGLAMS
Certifications & Qualifications
Bachelor’s Degree in Life SciencesAdvanced Degree (MSc, PhD, PharmD) Preferred
Industry Keywords
BiotechPharmaceuticalLabeling Review Committee (LRC)Global Labeling Committee (GLC)Regulatory ComplianceEU RegulationsUS RegulationsMarket Compliance Monitoring

Tech Stack

Tools & technologies
Apollo

About the role

Key responsibilities & impact
  • Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE).
  • Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
  • Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.
  • Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities.
  • Remain current with global labeling regulations and provide training to internal stakeholders.
  • Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation.
  • Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.
  • Support regional implementation of CDS updates and monitor compliance across markets.
  • Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.

Requirements

What you’ll need
  • Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
  • 5-7 years in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with global strategic leadership responsibilities.
  • Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
  • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
  • Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
  • Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
  • Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
  • Fluency in English (verbal and written); additional languages would be an asset.

Benefits

Comp & perks
  • Health insurance
  • 401(k) matching
  • Flexible working hours
  • Paid time off
  • Professional development opportunities