Fidel Torreiro

Fidel Torreiro’s professional journey spans more than two decades in global executive roles within Pharma R&D. Over his career, he has been responsible for delivering complex R&D programs, driving corporate reorganizations, overseeing product launches, and developing innovative market access and marketing strategies. In 2018, he founded a Regulatory Affairs consultancy, and in 2021, he co-founded a training company specializing in leadership and team development programs.

Fidel’s previous roles include EU Regulatory Affairs Lead at Eledon, Regulatory Affairs Director at AstraZeneca, and Global Regulatory Lead at PharmaMar. He has also served as International Lead at Mallinckrodt, Regulatory Affairs CMC Lead at Summit Pharmaceuticals, and Regulatory Affairs Associate Director at both AbbVie and Abbott. His earlier career includes positions in Global Regulatory Development at Norgine, Corporate Quality Assurance at Almirall, and as a Community Pharmacist.

As a seasoned Regulatory Affairs Strategist, Fidel brings a comprehensive understanding of the development, market access, and commercialization challenges across global, regional, and local landscapes. He is highly skilled in product development strategies spanning Phase I to launch and lifecycle management, with expertise in regulatory filings, orphan and rare diseases, scientific advice, and advisory boards. His corporate expertise extends to designing and implementing reorganization initiatives and operating models to optimize regulatory functions.

Fidel’s therapeutic experience includes antivirals, oncology, antibiotics, immunosuppressants (for transplants), renal, gastrointestinal, and central nervous system disorders. He has worked with a variety of small molecules, biologicals, including antisense oligonucleotides (ASO) and monoclonal antibodies (mAB) therapies, addressing both rare and mainstream diseases. His functional expertise encompasses regulatory and peri-registration activities, ensuring seamless progression from development to market.

His qualifications include a Professional Certificate in Executive Coaching (Henley Business School, 2021), an MBA (Henley Business School, 2016), a Master’s in Pharmaceutical Industry & Medical Devices (CESIF, 2003), and an MPharm degree from the University of Barcelona (2000).

Throughout his career, Fidel has achieved numerous milestones. He led the implementation of a global Regulatory Affairs operating model and reorganization, orchestrated successful Agency Scientific Advice meetings, and developed regulatory acceleration and market access strategies for complex Phase III studies. His leadership has resulted in industry best-in-class outcomes, such as an EU marketing authorization strategy yielding a record 8-month approval and launch strategies enabling market entry in the UK and Germany within 24 hours of EU commission decisions.