Parexel

Parexel

Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist

United States - Remote · Senior

Sponsorship not specifiedDetected 15 days ago
AccessibilityProduct ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft OfficeSharePointRegulatory Affairs

About the role

  • From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
  • Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
  • We take our work personally, we do it with empathy and we're committed to making a difference.

Responsibilities

  • 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.
  • Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team-set agendas, drive decisions, and ensure timely implementation.
  • Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets.
  • Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust version control and SOP adherence for audit readiness.
  • Manage change control documentation, specimen requests, and verify part numbers for correct submissions.
  • Support regional implementation of CDS updates and monitor compliance across markets.
  • Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices.
  • This is an opportunity to shape global labeling strategy, lead governance processes, and ensure patients worldwide receive accurate and compliant product information.

Requirements

  • 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.
  • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
  • Education:
  • 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.
  • Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
  • Technical Expertise:
  • Core Competencies:

Nice to have

  • Bachelor's degree in Life Sciences or related field
  • advanced degree (MSc, PhD, PharmD) preferred.
  • Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
  • Demonstrated problem-solving ability with risk analysis and sound decision-making.
  • Proficient regulatory knowledge, including scientific concepts within labeling and their global implications.
  • Attention to detail with the ability to think strategically.
  • Fluency in English (verbal and written)

Skills

  • Strong collaboration skills, with experience working in global, cross-cultural, matrix environments.
  • Organizational skills to interact seamlessly both internally and externally on compliance matters.
  • Effective communication skills for explaining concepts, options, and impacts.

Compensation

  • Lead annual strain updates for Northern/Southern Hemisphere flu campaigns.
  • Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting.

Benefits

  • Global Implementation & Health Authority Engagement
  • Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations.
  • Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.
  • Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.

Equal opportunity

  • EEO Disclaimer
  • equal opportunity employer.
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.