Background

Linda Rawlings BSc (Hons), MTOPRA

Linda is Principal Regulatory Consultant and a Director of empatec ltd, responsible for overall project delivery and is the first point of contact for clients. She is an experienced regulatory professional with a sound technical background and specialist knowledge of pharmaceutical regulatory affairs and product development strategies. Linda has previously worked in large pharmaceutical companies and small early stage companies and is well placed to understand the needs of our broad client base.

Linda's career began at Smith & Nephew Research as project leader and Head of Microbiology. She moved into regulatory affairs initially with Fison's, followed by Schering Plough and then worked as an independent regulatory consultant, gaining experience across a number of therapeutic areas and product types including inhalation products, oral anti-infectives, biological implants and over-the-counter medicines including legal category changes. She has spent time at the University of York facilitating research collaborations with regional SMEs, and commercialising bioscience as General Manager of Bioincubator York Ltd. Linda held board positions with two oncology-based University spin-out companies.

From July 2004 to March 2006 Linda spent part of her time as Programme Manager of the Yorkshire Forward-funded Specialist Bioscience Advisory Service which provided advice to bioscience SMEs across the Yorkshire and Humber region through business consultants Deloitte and law firm Eversheds. She has supported the regional bioscience cluster, speaking at the White Rose Bioscience Forum in 2003 and 2005, and delivering the session on regulatory affairs for the innovative Bio2Work programme for new graduates run by the South Yorkshire Bioscience Enterprise Network in 2005.

Linda is a registered member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and has a degree in Microbiology from the University of Bath.

Aileen joined empatec ltd in September 2007 with a background in industrial microbiology and pharmaceutical and device quality assurance. As Regulatory Affairs Associate, Aileen has experience in a variety of pharmaceutical regulatory submissions and maintains a particular interest in the drug / device interface, quality systems and sterile products.

Aileen's career also began at Smith & Nephew Research, originally working with Linda in the Microbiology Laboratory and later becoming the Head of Microbiology. After 5 years experience as a microbiologist and manager in a research/GLP environment, she moved into quality assurance, as Quality Assurance Manager at the new Smith & Nephew Research Centre in York. This move allowed her to gain experience with the management and audit of ISO 9000 and GLP quality systems. She was also involved with the application of GMP principles to the manufacture and release of clinical trial materials.

Aileen's particular interest in GMP led her to undertake QP training and then to take up the role of QA Microbiology Manager at the Smith & Nephew Wound Management manufacturing site. In this role she gained experience in the broader application of GMP and ISO13485 to the manufacture of medicines and medical devices respectively. She has particular expertise in the microbiological aspects of sterile product manufacture, environmental monitoring of cleanrooms and operation/validation of sterilization processes (steam, gamma irradiation and ethylene oxide).

Aileen is a member of BARQA (British Association of Research Quality Assurance), and has previously been a member of the Institute of Biology, the UK Panel of Gamma Irradiation Microbiology Group and the ABHI Microbiology Group. Her educational qualifications include a BSc and PhD in Microbiology and a Postgraduate Diploma in Pharmaceutical Quality and GMP. Her audit qualifications include Lead Assessor and Auditing Sterilization of Medical Devices.