Parexel

Senior Regulatory Affairs Consultant – Labeling

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇨🇦 Canada

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Job Level

Senior

Tech Stack

Apollo

About the role

  • Lead and coordinate labeling activities across foundational and non-foundational markets
  • Ensure compliance with global regulatory requirements
  • Maintain label governance and manage committees
  • Support advertising and promotional material review
  • Prepare administrative label updates for multiple markets (EU, US, AU, CH, DE)
  • Coordinate and manage EU administrative updates (e.g., address changes, Windsor updates)
  • Develop, manage, and track governance for company positions (DLS, CCDS, USPI and EU SmPC) and foundational markets
  • Maintain multi-market manuscripts and dependent market lists
  • Provide strategic input to therapeutic area teams and influence external labeling landscape
  • Prepare deviation documentation for non-foundational markets (DTT)
  • Manage GRA label compliance processes, including QC and oversight of labeling performance
  • Maintain FDA-508 compliance on US labels
  • Prepare documents for Labeling Review Committee (LRC) and run LRC meetings
  • Support label negotiations for foundational and other markets
  • Review and approve direct-to-consumer and marketing advertising, medical education, and social media content
  • Manage and proofread artwork for foundational markets
  • Prepare annual strain updates for Northern and Southern Hemisphere flu campaigns
  • Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting

Requirements

  • University degree (4-year) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering)
  • Advanced degree (MSc, PhD, PharmD) preferred
  • Minimum of 5-7 years in the biotech/pharmaceutical industry
  • At least 2+ years of labeling/regulatory experience with global responsibilities
  • Proven experience leading teams in a matrix organization
  • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
  • Experience in flu campaigns and pandemic products
  • Experience with direct-to-consumer and marketing advertising, educational materials, and social media
  • 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
  • Opportunity to make a global impact in regulatory affairs
  • Collaborative environment

Applicant Tracking System Keywords

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

Hard skills
labelingregulatory compliancelabel governancelabeling lifecycle managementdeviation documentationlabel negotiationsproofreadingflu campaign managementmatrix organization leadershipadvertising review
Soft skills
strategic inputinfluenceteam leadershipcommunicationorganizational skillscollaborationattention to detailproblem-solvingproject managementstakeholder management
Certifications
University degree in Life SciencesAdvanced degree (MSc, PhD, PharmD)