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.
The RA/PV Cluster Head is responsible for overseeing regulatory affairs and pharmacovigilance activities across a defined group of countries within the region. Operating in line with and complementary to the strategy set out by GRAS Regions and R&D, the role ensures compliant, efficient, and consistent execution of RA/PV responsibilities. As a key link between affiliate teams and regional/global functions, the Cluster Head provides strategic and operational leadership, drives performance, and ensures inspection readiness. With elevated accountability beyond in-country roles, the position supports capability building, cross-affiliate collaboration, and continuous improvement, while ensuring alignment with global standards and timely escalation of critical issues.
Main Responsibilities:
- Provide strategic and operational leadership to Affiliate RA/PV Leads across the cluster, ensuring effective execution of regulatory affairs and pharmacovigilance responsibilities in alignment with regional plans.
- Collaborate with Regional Therapeutic Area Leads and cross-functional partners to drive consistent, efficient, and compliant RA/PV processes across affiliates.
- Oversee end-to-end affiliate activities, ensuring timely delivery of key milestones, adherence to performance KPIs, and maintenance of compliance with Health Authority and company requirements.
- Establish and maintain a robust compliance framework in coordination with global and regional teams; monitor KPIs and inspection readiness across affiliates.
- Act as the point of escalation for affiliate RA/PV issues, ensuring effective issue resolution and risk mitigation.
- Ensure alignment between regulatory/PV strategies and Commercial Operations priorities to support integrated business planning.
- Foster collaboration across GRAS, R&D, Commercial, and Medical functions, and encourage cross-affiliate knowledge sharing and harmonised ways of working.
- Ensure accuracy and completeness of affiliate regulatory records in systems such as RIMS and oversee ongoing maintenance of compliance systems.
- Lead audit and inspection readiness activities, support regulatory inspections, and coordinate with QA to ensure timely and consistent responses.
- Support affiliate teams with structured onboarding, role-specific training, and ongoing capability development in line with GRAS regional strategy and local regulatory requirements.
- Monitor training effectiveness, address skill gaps, and promote a culture of continuous learning and operational excellence.
- Champion talent development and succession planning, fostering a high-performance and inclusive team culture across the cluster.
- Manage cluster-level RA/PV budgets, ensuring efficient allocation of resources aligned with business priorities.
- Oversee qualification and performance of local vendors and service providers, ensuring compliance with applicable regulatory requirements and internal standards.
- Maintain effective vendor oversight through performance monitoring and proactive risk mitigation.
Qualifications and Experience Requirements:
- A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification.
- Extensive experience (ideally 10+ years) in Regulatory Affairs and/or Pharmacovigilance at local, regional, or global level; strong preference for experience in a cluster or regional setting.
- Proven ability to influence stakeholders across the enterprise to maximise the impact and effectiveness of GRA and PV expertise, including proactive identification of opportunities to shape business-critical decisions.
- Skilled in applying a structured, systematic approach to stakeholder engagement, aligned with business objectives; experienced in navigating highly matrixed organisations and building effective cross-functional relationships across functions and cultures.
- Accountable for ensuring high-quality regulatory submissions and PV deliverables meet strategic objectives, are compliant with regional requirements, and are delivered on time.
- Builds and maintains strong working relationships with local Health Authorities and PV partners, demonstrating excellent communication and negotiation skills to support positive regulatory and safety outcomes.
- Solid understanding of GxP principles, including GMP, GCP, GLP, and GVP, with the ability to interpret and apply them across RA and PV contexts.
- Demonstrated leadership capability to lead, coach, & motivate diverse RA/PV teams to achieve shared goals, manage performance, and foster a culture of accountability and collaboration.
- Experienced in leading teams within a multicultural and cross-functional environment, promoting inclusion, continuous development, and high-quality delivery across varied geographies.
Competencies
- Highly effective communicator with written, verbal and presentation skills. Good administrative skills.
- Planning, organizing and time management skills, as well as attention to detail.
- Demonstrated ability to work across multiple disciplines.
- Ability to operate with minimal to no supervision and to establish professional, credible relationships within CSL Behring and externally.
- Provides recommendations and solutions to supervisor, manages projects and/or staff with minimal supervision.
- Fluent in English.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
Our Benefits
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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.
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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
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