Who is Franka?

My career in the pharmaceutical industry began in a Method Transfer Laboratory, where I worked as Deputy Laboratory Manager. 

In this role, I actively contributed to analytical method transfer and laboratory operations while ensuring compliance with GMP and GLP requirements. A key aspect of my work was coaching and training colleagues on quality standards, regulatory expectations, and best practices. I also supported audit activities, gaining valuable insight into quality systems, compliance management, and the importance of maintaining robust processes in highly regulated environments. 

Over the years, my career evolved from laboratory operations and analytcial sciences into Regulatory Affairs, CMC, Quality Assurance and Compliance. This progression provided me with a unique perspective across the entire product lifecycle, from development and quality control to global regulatory strategy and product registrations. 

Today, I bring more than 18 years of experience in the pharmaceutical industry, combining scientific knowledge, regulatory expertise, and strategic thinking. My international experience across Europe, US and other markets has strengthened my ability to navigate complex regulatory environments and build effective relationships with stakeholders across functions and cultures.