Ishbel is joining Kinesys Consulting as Executive Director Regulatory Affairs.
She has been working in the Pharmaceutical industry for over 30 years, starting as an analytical chemist and with 25 years in Regulatory Affairs.
She previously worked with Wyeth (now Pfizer), Controlled Therapeutics (now part of Ferring Group) and her own consultancy company, MacDonald Regulatory. Prior to becoming a consultant in 2000, she was Director of Regulatory and Clinical Affairs at Controlled Therapeutics Ltd, responsible for worldwide regulatory negotiation and approvals.
Ishbel has provided regulatory advice and been involved in many types of regulatory applications in development, licensing and post-licensing / life cycle management for a wide range of pharmaceutical and food supplement companies in Europe, US and Far East.
She has been responsible for most types of Regulatory Applications including Scientific Advice, Orphan Designations, CTAs, PIPs and MAAs. Ishbel specialises in working with Start-ups and SME’s on regulatory strategy, gap analysis, regulatory agency meetings, lifecycle management and regulatory due diligence.