Senior Portfolio Owner 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 also patients around the world. We are proud that our specialised business 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 ’.

• The job of the Senior Portfolio Owner Regulatory Affairs is to provide end-to-end ownership of all regulatory and product-related activities, ensuring a strong product strategy that supports compliance, product availability, patient safety, and effective risk management. The role acts as the central point of accountability and escalation while coordinating operations, driving regulatory strategy, and providing disciplinary and functional leadership to the product team. By fostering cross-functional alignment, prioritizing operational activities, and involving relevant experts when needed, the role ensures effective collaboration and high-quality outcomes across departments.
• Strategic Product & Regulatory Ownership
• End-to-end responsibility for all regulatory and product-related activities within the portfolio, ensuring a sustainable product strategy that supports compliance, product availability, patient safety, and effective risk management.
• Regulatory Strategy & Compliance Management
• Develop and drive the global regulatory strategy while overseeing all submission activities, agency interactions, and regulatory processes across the entire product lifecycle. Ensure compliance with all relevant national and international regulatory requirements.
• Team Leadership & Operational Management
• Provide disciplinary and functional leadership to the product team, including task prioritization, resource allocation, budget responsibility, and the continuous development of team capabilities and expertise.
• Cross-Functional Coordination & Stakeholder Management
• Ensure strong cross-functional alignment with internal departments, particularly SCM, Therapeutic Areas, and IMO, while acting as the central escalation point (SPOC) for regulatory and product-related topics.
• Risk Management & Strategic Decision-Making
• Assess complex regulatory and business risks and develop sustainable solutions under uncertain conditions with medium- and long-term impact on products, markets, and business objectives.
• External Partner & Outsourcing Oversight
• Lead and oversee external service providers and outsourcing activities, ensuring quality, compliance, performance, and professional communication with authorities and external stakeholders.
• Innovation, Governance & Continuous Improvement
• Continuously evaluate regulatory developments, market trends, and available methodologies to improve processes, strengthen governance structures, and support long-term organizational effectiveness.

• Academic Qualification & Industry Expertise
• Master’s degree in a relevant scientific or pharmaceutical discipline combined with more than 10 years of professional experience in Regulatory Affairs within the pharmaceutical industry.
• Leadership & Organizational Management
• More than 10 years of proven leadership experience managing large, cross-functional Regulatory Affairs organizations at senior management level, including extensive experience leading global and international teams.
• Conflict Resolution & Stakeholder Management
• Strong ability to manage and resolve conflicts at high organizational and political levels while maintaining effective collaboration across complex stakeholder environments.
• Communication & Influencing Skills
• Excellent indirect leadership, communication, and influencing skills across multiple hierarchical levels and in interactions with external stakeholders and regulatory partners.