Vice President, Regulatory Affairs, Pharma
Olga Carroll has more than 20 years of pharma, biotech & medical device industry experience in the US, EU, AP and OUS with large, medium and small-size companies. Broad and in-depth strategic and implementation end-to-end experience in the development and commercialization of small and large molecules, biologics and combination products in TAs of high unmet medical need with primary focus on oncology, hematology, neurology and Orphan/rare/ultra-rare adult and pediatric disease.
Subject matter expertise in global regulatory clinical strategy & competitive intelligence, commercialization of gene/cell therapies, CCDS/core label, GPV, collecting RWE to ensure reimbursement for the approved medicinal products; pre-clinical strategy, cross-functional project management.
Extensive regulatory, competitive and due diligence assessments; GAP/SWAT analyses in CMC, clinical, medical and regulatory strategy to ensure highest probability of regulatory approval and commercial success for the assigned platforms and assets. Global regulatory leadership of multiple cross-functional SMEs, strong analytical and organizational skills to solve complex problems and achieve set goals and milestones.
Some of the select clients Olga has done GRA strategy work for are Bayer, Pfizer, Mallinckrodt Pharam, Biogen, Sanofi-Genzyme, Boston Biomedical.