RAPV Cluster Head EU Mid-size

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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.