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Our Expert is a seasoned regulatory affairs leader with deep expertise in oncology and biologics. Currently heading Global Regulatory Affairs at a Start-Up, she oversees global submission strategies, regulatory compliance, and lifecycle management for oncology products.

 

Before joining, she held a senior leadership role at a top 10 pharma company where she managed regulatory strategies for oncology pipelines. She was instrumental in navigating complex regulatory landscapes across multiple regions, supporting product approvals and market access. She also played a critical role in regulatory response planning during critical phases of clinical development.

 

Prior to that role, she worked as a Senior Consultant in Regulatory Affairs and Clinical Development Strategy, advising biotech and pharma companies on regulatory pathways, clinical trial strategy, and submissions, focusing on oncology and biologics. She also gained substantial regulatory experience at the Paul-Ehrlich-Institut, where she served as a Clinical Assessor reviewing biologics and comparability exercises, further strengthening her knowledge of regulatory requirements in vaccine and biologics development.

 

She began her career in a leading pharmecutical company in Regulatory Affairs for vaccines, where she was involved in regulatory submissions and compliance during vaccine development phases, gaining foundational expertise in vaccine regulations and global standards.

 

She holds a formal qualification in Regulatory Affairs from Rheinische Friedrich-Wilhelms-Universität Bonn and completed her medical Approbation at Heinrich-Heine-Universität Düsseldorf, underpinning her scientific and regulatory knowledge with clinical insight.