Sandra brings over 24 years of experience in the pharmaceutical and management consultancy sectors, with deep expertise in regulatory strategy and global market access. Throughout her career, she has led complex regulatory initiatives across Europe and internationally, working closely with National Competent Authorities and regulatory bodies in both established and emerging markets.
She has successfully overseen the submission of more than 950 Marketing Authorizations in the EU, leveraging both National and European procedures, and has been directly involved in the development of Modules 1 to 5. Sandra is recognized for her strategic approach to dossier preparation, regulatory compliance, and her precision in navigating approval processes worldwide.
In addition to initial submissions, Sandra has substantial experience in post-marketing regulatory activities, having led and supported over 2,000 global regulatory procedures, including renewals, variations, and other lifecycle management processes. Her ability to maintain compliance and product availability across multiple markets demonstrates her comprehensive understanding of regulatory maintenance. She is also adept at handling responses to deficiency letters and addressing regulatory challenges efficiently, always with a focus on maintaining momentum and minimizing time to market.
Sandra is an active member of the regulatory affairs community and holds the MTOPRA designation. For the past three years, she has served as a Working Party member for the TOPRA Symposium, contributing to the planning and delivery of key regulatory discussions. She is passionate about fostering collaboration between industry and regulators, mentoring emerging regulatory professionals, and championing excellence in regulatory science.
As a TOPRA Awards judge, Sandra brings a deep understanding of regulatory complexity, a commitment to quality, and a strong appreciation for innovation and impact in the field.