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Anna Malinowska - Cytiva

Anna Malinowska

Lead Regulatory Strategist - Biologics Mnufacturing, Cytiva

Anna Malinowska has over 15+ years of expertise in the pharmaceutical industry gained at GSK in Poland and Sandoz in Germany.  Since December 2024, she has been working at Cytiva, where she supports global regulatory strategies and complex development programs. She specializes in regulatory affairs across the EU and global markets (EU and RoW), with a proven track record in handling Marketing Authorisation Applications (MAAs) and leading cross-functional teams.

She began her career as a Product Development Scientist and Deputy Quality Manager at Sensapharm Ltd in the UK, where she contributed to Medicines for Malaria Venture- funded project on the metabolic profiling of Artemisia annua leaves, with results published in a peer-reviewed medical journal.

Her key achievements include CMC lifecycle management of various pharmaceutical products, post-approval changes (with particular expertise in CTD Modules 2.3. and 3), drafting responses to Health Authority requests, preparing renewal dossier and navigating complex regulatory landscapes.

Anna holds a master’s degree in Biotechnology and Postgraduate Diploma in Clinical Trials Monitoring. She is also an active member of the regulatory Affairs Professional Society (RAPS).

Based in Poznan, Poland, she lives with her husband and two children.  Outside of work, she enjoys travelling to sunny destinations with a beach, baking, fashion and spending time with her family.

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