She provides strategic regulatory support to SFL clients for the development, filing and maintenance of healthcare products, with proven ability to develop and implement regulatory strategies for a broad range of product types, including small molecules, biologics, cell and gene therapies.
Leading international regulatory projects and by interacting with Regulatory Authorities, clients and cross-functional teams on a regular basis, she has gained experience in senior level negotiations and supervises a team of high performing regulatory affairs professionals.
She has extensive knowledge of regulatory procedures and hands-on experience in preparing high quality regulatory documentation, such as CTAs, Meeting Requests, Marketing Authorization Applications and variations.
Anja holds a MSc degree in Biology from Albert-Ludwigs-University Freiburg, Germany. During her studies, she focused on Biochemistry, Cell Biology, Immunology and Pharmacology.
SFL Regulatory Affairs & Scientific Communication Ltd.