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

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

ATS Keywords

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Hard Skills & Tools

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

Certifications

Bachelor’s Degree in Life SciencesAdvanced Degree (MSc, PhD, PharmD) Preferred