Associate Director, PV & Reg Platform

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Position Description Summary

The Associate Director, PV & Reg Platform supports the execution and operational delivery of PV and regulatory platforms, ensuring that system features align with business needs and compliance obligations. Assists with platform optimization, issue resolution, and cross-functional coordination.

Main Responsibilities

• Manage platform configuration, testing, and release planning for safety and regulatory systems.
• Support delivery of platform enhancements and ensure alignment with user needs.
• Collaborate with PV, regulatory, and IT teams to coordinate system upgrades and integrations.
• Monitor platform performance and contribute to the development of improvement plans.
• Assist in vendor coordination and service management to maintain compliance standards.
• Track platform KPIs and inspection readiness support documentation.

Qualifications and Experience Requirements

• Bachelor’s or Master’s in Life Sciences, Regulatory Affairs, Health Informatics, or related field.
• 10+ years of experience in PV operations, regulatory systems, or R&D digital operations.
• Working knowledge of global regulatory processes and safety systems (e.g., Argus, Vault RIM).
• Strong project coordination and documentation skills.
• Experience supporting audits or inspections is a plus.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

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.

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 Inclusion and Belonging | CSL

Do work that matters at CSL Behring!