Kerstin Malm
Senior Consultant
M Sci Pharm
kerstin.malm@regsmart.se +46 70 728 95 28
Kerstin is a pharmacist and regulatory affairs specialist with more than 15 years of experience from the pharmaceutical industry and the Swedish Medical Products Agency.
More about Kerstin
Kerstin has broad strategic and operational experience across the pharmaceutical product lifecycle. Her work has included scientific advice procedures, paediatric investigation plans, clinical trial applications and modifications, IND updates, global market expansion, marketing authorisation applications and product lifecycle management.
Her background includes senior regulatory roles at pharmaceutical companies and consultancy organisations, as well as experience as a procedure coordinator at the Swedish Medical Products Agency. This combination gives her a practical understanding of both industry needs and regulatory authority expectations.
Kerstin supports clients with regulatory strategy, health authority interactions, submission planning and execution, marketing authorisation applications, post-authorisation activities and product information.