Parexel

Senior Regulatory Affairs Consultant – Labeling

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Apollo

About the role

  • 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.
  • Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.

Requirements

  • 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.
  • Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
  • Fluency in English (verbal and written); additional languages would be an asset.
Benefits
  • Health insurance
  • Flexible work arrangements

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
labeling strategylabeling document managementclinical data interpretationregulatory compliancelabeling lifecycle managementnegotiation with Health Authoritiescross-functional team leadershipstrategic risk identificationcontent alignmentglobal labeling regulations
Soft skills
influence stakeholderscultural sensitivityorganizational skillsdecision-makingtraining internal stakeholdersagenda settingtimely implementationcommunication skillsleadershipcollaboration
Certifications
Bachelor’s degree in Life SciencesMScPhDPharmD