Acts as operational interface for pharmacovigilance and regulatory affairs teams at CSL Behring. Manages platform implementation and optimizes regulatory processes in compliance with global standards.
Responsibilities
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.
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