Helen Spain, BSc BTec

Senior Partner

Email: helen.spain@transcrip-partners.com

Helen is a senior regulatory professional with over 22 years drug development experience and 14 years within global regulatory affairs at Pfizer. Helen worked in pharmaceutical research and development for 7 years before transitioning into global regulatory affairs, holding positions of increasing responsibility in both European and global regulatory areas, including managing and developing EU regulatory strategy teams and global regulatory project teams. Helen has a broad global regulatory strategy knowledge base spanning EU, US, Japan, Canada and Emerging Markets.

Key areas of expertise include global regulatory strategy, paediatric development, orphan disease development, seeking global scientific advice and Regulatory Agency interactions (including FDA Advisory Committee experience, EU oral explanations, China, Japan regulatory interactions). Helen has also attained a broad therapeutic area knowledge base including cardiovascular, pulmonary vascular disease, allergy and respiratory, CNS, ophthalmology, genitourinary/gastrointestinal and infectious diseases. Helen has a consistent record in leading and managing complex regulatory submissions and rapid response activities on a global level and was instrumental in the MAA/NDA approval successes for Relpax, Zeldox, Aricept and Revatio.

Helen has a BSc (Hons) in Pharmaceutical Sciences from the University of Greenwich and is an active member of TOPRA.