Description
Summary
Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams, ensuring platform design, delivery, and operations support safety, compliance, and submission needs. This role will focus on optimizing platforms to streamline PV and regulatory processes, ensuring alignment with global standards and regulatory requirements.
Main Responsibilities & Accountabilities
•Serve as point of contact for both PV and regulatory platform design, delivery, and operations•Oversee the setup, integration, and ongoing governance of PV and regulatory platforms•Own and manage the PV and regulatory platform roadmap, ensuring it meets the evolving safety, regulatory, and compliance requirements•Lead cross-functional collaboration with clinical, IT, and external regulatory bodies to enhance platform adoption and submission efficiency•Manage platform optimization to support continuous compliance, efficiency, and scalability across both PV and regulatory domains•Drive process improvements and ensure that both PV and regulatory platforms are fully aligned with business and regulatory needs•Partner with the R&D and Enterprise Data, Automation and AI teams to advance the digital capabilities to transform the R&D Operating model
Qualifications & Experience 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•Proven leadership in managing cross-functional teams, projects, and vendor relationships•Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA) and safety data systems•Experience in PV system audits and inspections
Our Benefits
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 to see what’s available to you as a CSL employee.
About 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,. Our parent company,, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
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 .
Do work that matters at CSL Behring!