Sr. Director of Regulatory Affairs
Thermo Fisher Clinical Research Group, Portugal
Carla Gomes is a Regulatory Affairs Senior Director with more than 20 years of experience across global regulatory strategy, product development strategy, and rational product design. She has an extensive experience in full development, licensing, and lifecycle management of pharmaceutical and biotechnology products across therapeutic areas with practice in pharmaceutical companies, competent authorities, distribution and logistics as well as management of global teams with direct and indirect reports. Carla has successfully and creatively coordinated global Phase 1-4 clinical trials, requiring seamless collaboration with a global cross-functional team, frequent liaison with regulatory authorities and clients and rapid turnaround of responses. She holds a degree in Pharmaceutical Sciences and a Master in Pharmaceutical Technology (curricular program) from the University of Pharmacist of Oporto, an MBA (Master’s in Business Administration) from the Catholic University (Economics, University of Oporto), and a Master in Regulation and Evaluation of Medicines and Health Products from the University of Pharmacy of Lisbon. Carla Gomes is an Expert in Regulatory Affairs attributed by the Pharmaceutical Society. She leads Regulatory Science at PPD, a part of Thermo Fisher Scientific.
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