Supports the strategic execution and governance of pharmacovigilance (PV) and regulatory platforms to ensure operational efficiency, compliance, and scalability. Drives cross-functional collaboration and system optimization to meet evolving regulatory and safety requirements.
Act as a primary interface with PV and regulatory teams for platform implementation and enhancements.
Lead day-to-day oversight of platform integration, maintenance, and user support.
Contribute to the development and execution of platform roadmaps to meet business and regulatory objectives.
Ensure alignment of platform features with global safety reporting and regulatory submission requirements.
Drive improvements in data workflows, submission processes, and inspection readiness.
Collaborate with clinical, IT, and regulatory partners to streamline and optimize platform use.
Support vendor engagement and service delivery to ensure platform performance and compliance.
Bachelor’s or Master’s in Life Sciences, Regulatory Affairs, Health Informatics, or related field.
10+ years of experience in pharmacovigilance, regulatory operations, or platform delivery.
Deep knowledge of safety data systems and electronic regulatory submissions.
Demonstrated leadership in matrixed teams and cross-functional initiatives.
Familiarity with global regulations (e.g., FDA, EMA, MHRA).
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.