Principal Consultant
Arriello
Jayne Hunt (PhD), Principal Consultant at Arriello has over 30 years experience in regulatory affairs and provides regulatory advice and support throughout the full product life cycle and across a range of therapeutic areas for biological, new chemical entities and advanced therapy medicinal products (ATMPs).
Jayne’s operational and strategic experience in regulatory product development and post-marketing arenas covers 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 as well as representing company regulatory departments at National Agency scientific advice meetings as well as meetings with the EMA and FDA.
Jayne has worked in several types of pharma companies: small (semi-virtual) environments, larger companies and consultancies. She also has regulatory experience of activities in Europe, North America, Latin America, Japan, and other rest of world countries. These activities span both development and post-marketing experience (small molecule, biological and ATMP) in therapeutic areas covering oncology, immunology, neurology, metabolic disease, dermatology, OTC indications and device submission and maintenance support. Jayne’s early development activities include submission of paediatric plans, EU & US expedited development documentation such as PRIME, fast track, breakthrough designation requests, global phase 1-4 studies and single country / regional submissions, including INDs.
Jayne has a BSc and PhD in Biochemistry and has also completed the TOPRA Postgraduate Diploma in Regulatory Affairs.
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Meeting EMA and FDA: Formal and Informal Pathways in Search of Alignment
Tuesday, May 7, 2024
13:45 – 14:45 CEST