Jolanda Lamers-Lemmers, PhD, started working in Regulatory Affairs in 2001 for one of world’s top 5 pharmaceutical companies. For the past 10 years, she is working as Sr. Regulatory Affairs Manager and MLT member at Starodub BV, where she provides consulting services on various aspects of (bio)pharmaceutical development and post-approval activities for amongst others Biotech products (recombinant proteins, ADCs, Vaccines, ATMP, mRNA, gene therapy). During her career, she has gained a lot of in-depth knowledge of international regulatory requirements. She has experience with Health Authority Scientific Advice meetings, development of worldwide regulatory submission strategies, including orphan products and accelerated review.