APAC Cluster Head- Reg Affairs/Pharmacovigilance

Your Opportunity:

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 APAC Cluster Head- RA/ PV 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.

Your Role:

• 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.

• A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• 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.