Elke Litzlbauer

Background

About Elke Litzlbauer

Long-term experienced global manager in External Manufacturing and Regulatory Affairs with over 19 years in the pharmaceutical industry. Specialized in product lifecycle management, contract manufacturing, divestment projects, and supplier relationship management with deep regulatory expertise. Known for developing strategic frameworks, leading cross-functional and cross-company teams, and ensuring regulatory, quality, and contractual compliance across complex global operations. Building relationships and trust has been essential to my success - whether in Regulatory Affairs, External Supply, or Contract Manufacturing. These elements have consistently enabled effective, collaborative partnerships. Taking ownership, speaking up, and guiding both individuals & teams are natural extensions of my leadership style and central to my professional journey. I am motivated by the challenge of leading with clarity and purpose, always keeping patient impact at the core. I value teamwork, efficiency, and strategic collaboration, grounded in personal values of trust, stability, and integrity. My goal is to foster long-term value and sustainable results through balanced & effective leadership. Building on this journey, I have developed a strong set of core competencies that enable me to create meaningful impact in roles I take on. Specific Knowledge & Expertise With a strong foundation in Regulatory Affairs, I bring extensive knowledge of global regulatory pathways, spanning CMC, clinical development, and post-market requirements. I am confident navigating complex regulatory landscapes and aligning with diverse stakeholder needs. In Supplier Relationship Management, I offer in-depth understanding of GMP-compliant networks and the seamless integration of suppliers into Quality Management Systems. I focus on building audit-ready, collaborative partnerships that support operational excellence and compliance. My Life Cycle Management experience extends across all stages—from early clinical development through commercialization to post-marketing surveillance. I provide strategic oversight to ensure compliance, continuous improvement, and long-term value across the product life cycle. Across all roles, I consistently apply core competencies in communication, strategic leadership, project/ program management, and informed decision-making. I bring additional strengths in risk management, compliance with strong attention to detail, contract and relationship management, and a strong focus on innovation, continuous improvement, and global cross-cultural awareness.