Philadelphia, Pennsylvania, United States
I’m a RAC-certified Regulatory Affairs CMC professional with nearly a decade of Pharma experience and 9 years working specifically in Cell & Gene Therapy (ATMPs). In 2024, I successfully defended the first marketing application for Adaptimmune’s TECELRA, targeting solid tumors (Synovial Sarcoma), after 4 years of late-phase CMC planning, project management, and plan execution. I’m passionate about Cell & Gene Therapy and CMC development, and I am not afraid of a challenge or hard work. My colleagues know me as a collaborative, resilient, and results-driven team player. If I sound like someone you might want on your team, please reach out. I'm a dual citizen of the United States and Spain and am authorized to work in the United States and EU.
Facet Life Sciences is a trusted, award-winning regulatory affairs and product development consulting firm, purpose-built for small life science companies. Our team brings authentic, science-first expertise to help emerging pharmaceutical, biotechnology, and medical device companies navigate the complex path to and through the US FDA. Unlike traditional "big pharma" models, our approach is tailored to meet the unique needs of smaller, entrepreneurial teams. We understand that early-stage innovators have different priorities, timelines, financial considerations, and risk profiles. That’s why we deliver strategic regulatory consulting, innovative development planning, and tactical execution designed specifically for scale, pace, and scientific ambition.
Contract regulatory writing to create regulatory documents for Pharmaceutical Companies. • Author and edit regulatory documents across all phases of drug development, in compliance with client specifications and regulatory authority guidelines. • Authors clinical documents in multiple therapeutic areas within established timelines and parameters. • Synthesizes data to facilitate review of document text • Assists senior level writers in authoring clinical and preclinical regulatory documents • Edits complex regulatory documents for scientific content, accuracy, format, consistency, compliance with internal specifications and external guidances. • Authored or edited BLA, NDA, and IND submission documents including Module 3/CMC, patient narratives, clinical study protocols, PSURs, DSURs, CSRs, and pre-Phase 3 briefing books • Authored or edited clinical trial disclosure (clinicaltrials.gov and EudraCT) and IBs