As a Senior Director, Regulatory Science, Carey assists international clients in the design and implementation of global product development plans and associated regulatory strategies. Carey brings extensive experience with IND/CTA, BLA/NDA/CTD, and global regulatory dossier submissions for novel therapeutic products, including biologics, small molecules, and nutritional therapies, resulting in successful initiation of clinical programs and marketing approvals. Carey brings to the role over 20 years of regulatory affairs experience in the development and execution of regulatory filing strategies in the US, EU, LACAN and AsiaPC for investigational and marketed products. Her broad regulatory experience covers pre-clinical, clinical, and CMC, from early stage development through to market authorization. Therapeutic areas that Carey specializes in include oncology, immune-oncology, and autoimmune diseases, together with experience in the codevelopment of biomarker IVDs.
Prior to joining VCLS, Carey worked in both small start-up biotechnology companies, as well as, in large international biopharmaceutical companies. In her regulatory role regulatory, Carey was a member of the senior leadership teams, developing and implementing comprehensive global regulatory strategies taking into account worldwide regulatory requirements, guidance from regulatory agency interactions, and the overall business goals of the organization. Carey has been actively involved in regulatory due diligence for in-licensing and partnering opportunities, presentatons for raising venture capital financing and private investments, and establishing regulatory affairs departments.
Carey received her Master’s of Science from the New York University Sackler Institute in Molecular Biology with a focus on signal transduction, specifically investigating the role of the JAK/STAT signaling pathways in oncolytic diseases.
Carey is based in Florida, and frequently commutes to VCLS offices in Cambridge, MA.