Jayne Hunt

Biography

Dr Jayne Hunt is a Regulatory Affairs professional with almost 25 years’ experience in both the regulatory product development and post marketing arenas supporting CMC, Non-clinical, Clinical, Labelling and Safety activities,  including variations, renewals and other post marketing requirements for biologicals and small molecules within the Ethical, Generic and CRO environments. Jayne has a wide breadth of development experience in many therapeutic areas in both small (semi-virtual) environment (Phytopharm Plc), larger companies (Merck Generics, Lundbeck, Solvay, Janssen-Cilag, Takeda) as well as CROs (PPD, Parexel). Jayne began her career in the Pharmacovigilance Department at the MHRA before moving into the Pharmaceutical Industry where she supported Global Phase 1-4 studies and single country / regional submissions, including First in Human INDs.  Jayne has coordinated regulatory strategy activities and support for immunology, dermatology, CNS development teams for Europe, North America, Japan, Latin America and other rest of work countries. Jayne has a BSc and PhD in Biochemistry and has also completed the TOPRA Postgraduate Diploma in Regulatory Affairs.

Research Interest

biologicals and small molecules within the Ethical, Generic and CRO environments.