Global Head of Regulatory Affairs (m/f/d)

We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market. This benefits not only our partners, but so patients around the world. We are proud that our economy model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE'.

In the role as Global Head of Regulatory Affairs, you lead a global organization of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs and drive regulatory strategies for the established product portfolio, focusing on product integration, lifecycle management, and sustained market supply. You ensure effective end-to-end regulatory lifecycle management, including submissions, variations, and maintenance of market authorizations, while partnering cross-functionally to position Regulatory Affairs as a strategic enabler of product value, patient access, and long-term portfolio. Regulatory Strategy & Portfolio Management Develop and maintain evolve regulatory strategies for the established product portfolio across CMC Regulatory and Regulatory Affairs. Oversee regulatory-driven portfolio performance to ensure sustained market supply, portfolio continuity, and support for financial objectives. Lead regulatory contributions to product integrations, ensuring successful transfer and maintenance of market authorizations across the lifecycle. Regulatory Governance & Strategic Decision-Making Hold ultimate accountability for global regulatory compliance and the maintenance of all market authorizations worldwide. Oversee all regulatory assessments during due diligence activities, including the evaluation of regulatory risks, timelines, and integration. Make high-impact regulatory and strategic decisions affecting approvals, lifecycle changes, and long-term portfolio sustainability. Cross-Functional Collaboration & Operational Excellence Guide cross-functional teams to ensure effective regulatory lifecycle management and execution across products. Foster strong alignment with enabling functions to ensure efficient use of enterprise systems, processes, and data in support of regulatory and execution. Global Leadership & Team Development Lead and develop a global team of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs, fostering collaboration, accountability, and operational excellence across the organization.

Education & Regulatory Expertise You hold a Master's degree in a relevant scientific or pharmaceutical discipline and bring more than 10 years of professional experience in Regulatory Affairs within the pharmaceutical industry. In addition, you possess deep expertise in global regulatory and submission processes across multiple markets. Leadership & Organizational Management You have a proven track record of leading large regulatory organizations at senior management level and bring at least 10 years of leadership experience, ideally within international and globally distributed teams. Stakeholder Management & Communication You demonstrate a strong ability to build and maintain long-term relationships with regulatory authorities and external partners. In addition, you excel in communication and leadership, including indirect management across different hierarchical levels.

Corporate culture & internationality A growing company with a diverse, open working environment and employees from around 40 countries. Flexible working models & work-life balance Individually customisable working models, including the option to work from another EU country for up to two months per year. Working time account with compensatory time off and 30 days of holiday. Individual benefits & pension provision Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or benefits for travel and meal costs. Discounts & additional benefits Access to the corporate benefits platform with discounts at hundreds of partnership companies. Further development & team culture Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and successes together. .