Kathrin Thomas is a seasoned Regulatory Affairs executive with nearly 25 years of diverse experience across blue-chip pharmaceutical companies, emerging biopharma ventures, and consulting environments. As the Principal Consultant and Managing Member at Senita Consulting, LLC, she leverages her extensive expertise to serve as a...
Kathrin Thomas is a seasoned Regulatory Affairs executive with nearly 25 years of diverse experience across blue-chip pharmaceutical companies, emerging biopharma ventures, and consulting environments. As the Principal Consultant and Managing Member at Senita Consulting, LLC, she leverages her extensive expertise to serve as a regulatory advisor and on-demand Head of Regulatory for various biotechnology and pharmaceutical sponsors. Kathrin's role is pivotal in guiding clients through the complex landscape of regulatory requirements, ensuring compliance and strategic alignment with health authority expectations.
Her deep understanding of regulatory frameworks allows her to effectively manage, author, and review critical health authority meeting documents, special designation requests, and regulatory submissions. Kathrin's proficiency in interacting and negotiating with regulatory bodies such as the FDA, EMA, and Health Canada is complemented by her solid project and program management skills, underscored by her PMP certification. This unique combination enables her to lead cross-functional teams in navigating the intricacies of regulatory pathways, from initial product development through to market authorization.
Kathrin's assignments across Europe and the United States have further enriched her perspective, allowing her to provide strategic interpretation of health authority regulations and guidance tailored to the needs of her clients. Her fluency in German and Spanish enhances her ability to engage with international stakeholders, fostering effective communication and collaboration. With a robust background in Chemistry, Manufacturing, and Controls (CMC) and technical product development, Kathrin Thomas stands out as a trusted partner for organizations seeking to streamline their regulatory processes and achieve successful product launches in a competitive market.
