About me
Margaret Studzinska, MBA is a Senior Director in Regulatory and Medical Writing, with over 15 years of experience in medical and regulatory writing for the clinical research and pharmaceutical industries. She has supported multiple regulatory submissions to global health authorities such as FDA (US) and EMA (EU). Her regulatory document expertise includes writing clinical, non-clinical, and CMC documents. Her key responsibilities include diverse workforce management, providing technical guidance to the team, and training writers on various regulatory documents.
