Olga Neumueller serves as the Director and Therapeutic Area Lead for Global Regulatory Affairs in the Europe region at CSL, where she leverages her extensive background in pharmacy and biochemistry to drive regulatory strategies that align with both commercial objectives and global standards. With a...
Olga Neumueller serves as the Director and Therapeutic Area Lead for Global Regulatory Affairs in the Europe region at CSL, where she leverages her extensive background in pharmacy and biochemistry to drive regulatory strategies that align with both commercial objectives and global standards. With a robust 15 years of experience in the pharmaceutical and biotech sectors, Olga has honed her expertise in the regulatory landscape, particularly in the development and lifecycle management of small molecules and biologics, including both originator and generic products.
In her current role, Olga leads a dedicated Regulatory Affairs team focused on specific therapeutic areas, ensuring that regulatory strategies are not only comprehensive but also adaptable to the evolving market dynamics. She is instrumental in planning and executing regulatory submissions from early development phases through to marketing authorization and post-approval activities. Her ability to engage with health authorities and foster direct interactions is a testament to her strong professional communication skills and strategic thinking.
Key projects under her leadership often involve navigating complex regulatory environments, where her knowledge of drug regulatory affairs and her RAC certification come into play. Olga's commitment to organizational culture change and people management is evident as she mentors her team, fostering an environment of collaboration and innovation. Her executive leadership skills enable her to effectively present regulatory strategies to internal stakeholders, ensuring alignment and support across the organization. As a result, Olga Neumueller not only contributes to the successful launch of new therapies but also plays a pivotal role in shaping the future of regulatory practices within CSL and the broader industry.
