Hybrid Senior Director, PV & Regulatory Platform Lead

Posted 3 weeks ago

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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.

Job title

Senior Director, PV & Regulatory Platform Lead

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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