Jeremy Brace has over 30 years of experience in the Pharmaceutical industry with over 20 years working in Regulatory Affairs in the US and Europe. Working with companies such as Novartis and Hoffman La Roche, he has gained extensive experience of product development strategies at all stages of a product life cycle. Most recently, Jeremy was Vice President of Regulatory Affairs at Sirion Therapeutics Inc. Jeremy is a graduate of the University of Warwick, England with a degree in Biological Science and has a diploma through the British Institute of Regulatory Affairs.
- Submission and approval of numerous regulatory applications including over 10 NDA/MAA’s, more than 20 IND/CTA’s, and 3 Orphan Drug applications.
- Development of successful product life cycle strategies for both drugs and biotech products across therapeutic areas, including Ophthalmology, Oncology, Rheumatology, CNS, Dermatology, Diabetes, Pain Management and Osteoporosis.
- Regulatory lead for numerous health authority meetings and interactions including Advisory Committee meetings, pre-NDA meetings, End of Phase 2 meetings, pre-IND meetings and others.
- Extensive experience of the preparation and review of promotional and advertising materials for compliance in the US and around the world.
- Issue management of a number of high profile media related product issues.