Elaine MortonPharmaceuticals Regulatory Consultant
Tel 0131 226 8200
M 07973 550 106
Elaine is a regulatory professional with over 20 years of global drug development experience, predominantly obtained in small and start-up pharmaceutical companies.
She brings considerable experience in global pharmaceutical pre-and post-marketing. She provides Regulatory, Development, Quality, and Technical Due Diligence services to the pharmaceutical industry and provides expertise in all aspects of drug development, marketing and product life-cycle management.
Elaine has supported several private start-up/mid-sized entities with early phase drug development, manufacturing, compliance and fund-raising activities. Elaine spent 17 years at the Medicines Company (part of the Novartis group) working on regulatory affairs, and latterly was a Vice President, Head of Global Pharmacovigilance with responsibility for global pharmacovigilance activities and risk management strategies across a portfolio of commercialised and development products. She has authored many key regulatory documents including expert reports, SmPC’s, study reports, RMP’s, PSUR’s, DDPS, DSUR’s, PIPs etc. Elaine brings extensive drug development experience and a broad compliance understanding (GCP, GDP, GMP, promotion and advertising). Her expertise covers a broad range of territories, cultures and regulatory agencies.
Additionally, Elaine has held senior roles in regulatory affairs at British Biotech Pharmaceuticals and Shire Pharmaceuticals. She holds a British Institute of Regulatory Affairs Diploma with Distinction, a Post-Graduate Certificate of Education (Oxford University), a PhD: Molecular Exploration of the Hypersensitive Response (Bath University), and a B.Sc. (Hons) in Applied Biology (North East London Polytechnic).
A self-confessed Francophile, Elaine also enjoys gardening, skiing and yoga.
Qualifications:British Institute of Regulatory Affairs Diploma
Post-Graduate Certificate of Education
PhD in Molecular Exploration of the Hypersensitive Response
B.Sc. (Hons) in Applied Biology