Senior Director, PV & Reg Platform Lead

Position Description Summary

Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams, ensuring technology 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
• 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, ensuring it meets the evolving safety, regulatory, and compliance requirements.  Responsible for lifecycle management, governance, release planning, and operational health for these platforms
• Build and maintain strong relationships with regulatory and PV business stakeholders, ensuring their requirements are captured and prioritized in platform design and process optimization.
• 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 (e.g., Veeva Regulatory and Safety, Argus Safety Solutions…etc.)

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 benefits site to see what’s available to you as a CSL employee.

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!