Linda has over 20 years’ experience in regulatory affairs covering operational and strategic roles, both pre- and post-approval, working with pharmaceutical companies of all sizes.
After starting her career in R&D at Smith & Nephew, she worked in global and local regulatory roles with Fisons and Schering Plough, and as an independent consultant. She has managed a diverse project portfolio across a number of therapeutic areas and product types including inhalation products, oral anti-infectives, biological implants and over-the-counter medicines. She has successfully managed a number of legal category changes.
From 2001, Linda spent 2 years working at the University of York facilitating research collaborations with regional Small & Medium sized Enterprises, and commercialising bioscience as General Manager of Bio-incubator York Ltd. She also held board positions with two oncology-based University spin-out companies giving her a good understanding of the needs of early stage companies as well as those of larger organisations.
Linda set up Empatec Regulatory Services in 2003 which continues to support a broad and growing range of clients with their regulatory needs. Linda is a member of DIA and is a registered member of TOPRA (The Organisation for Professionals in Regulatory Affairs), and has a degree in Applied Biology specialising in Microbiology from the University of Bath.
We are an experienced team of consultants with a track record of delivering results.