CSL

Senior Director, PV & Regulatory Platform Lead

CSL

full-time

Posted on:

Location Type: Hybrid

Location: Maidenhead • 🇬🇧 United Kingdom

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Job Level

Senior

About the role

  • Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams
  • Manage platform implementations, updates, and optimization of system solutions for regulatory document management, registration tracking, compliance management, submission, publishing, and safety case processing
  • Oversee the setup, integration, and ongoing governance of PV and regulatory platforms
  • Own and manage the PV and regulatory platform roadmap
  • Build and maintain strong relationships with regulatory and PV business stakeholders
  • Drive process improvements and ensure alignment with business and regulatory needs
  • Partner with the R&D and Enterprise Data, Automation and AI teams to advance digital capabilities

Requirements

  • Bachelor's or Master’s in Life Sciences, Regulatory Affairs, Health Informatics, or related field
  • 12+ years of experience in pharmacovigilance, regulatory affairs, R&D operations, or platform management
  • Expertise in safety data systems, regulatory submission processes, and platform technologies (e.g., Veeva Regulatory and Safety, Argus Safety Solutions…etc.)
  • Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA) and safety data systems
  • Experience in PV system audits and inspections
Benefits
  • CSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
  • Committed to the wellbeing of our employees and their loved ones.
  • Offers resources and benefits, from health care to financial protection.

Applicant Tracking System Keywords

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

Hard skills
pharmacovigilanceregulatory affairsplatform managementsafety data systemsregulatory submission processesprocess improvementssystem solutions optimizationcompliance managementsubmission publishingsafety case processing
Soft skills
relationship buildingstakeholder managementprocess alignmentcollaborationgovernance