UP
Area Director supervising the launch and performance of Postino WineCafe locations in Greater Chicago Area. Managing teams, ensuring operational excellence, and achieving sales goals.
About the role
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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