RA / PV Cluster Head DACH

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

We encourage you to make your well-being a priority. It’s important and so are you.

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