BIO-CAT is pleased to announce the hiring of Elaine Cooling as regulatory affairs manager. Elaine comes to BIO-CAT with 20 years’ experience in quality, regulatory and manufacturing support roles in the pharmaceutical industry, most recently with Allergen Pharmaceuticals International. Elaine’s role will oversee the daily regulatory needs of BIO-CAT’s customers, play a vital role in defining regulatory requirements for BIO-CAT’s strategic plan and interface with key regulatory agencies. Elaine relocated from Ireland to Virginia in August 2017.
Elaine has a master’s degree in Industrial Pharmaceutical Science, an honors degree in Pharmaceutical Chemistry from Coventry University, UK and a diploma in Pharmaceutical Science from Sligo IT, Ireland. In 2005, Elaine became a “Qualified Person” or QP, certified by the Royal College of Surgeons in Ireland/Sligo IT. Prior to sale, the QP reviews each batch of medicinal product that has been manufactured and tested to certify it is in compliance with the laws of the European Union.