Embley, PGDPRA, MTOPRA
Regulatory Science, Drugs & Biologics
Peter brings over 19 years applied industrial and commercial biopharmaceutical experience to his role, including seventeen years in Regulatory Affairs; working within the Generic, R&D and CRO industries. Peter has a strong grounding in EU legislation and filing strategies and has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams.
Peter’s collective experience reflects a balance of regulatory experience in Drug Development and Lifecycle Management. He has managed several ANDA applications during his time at Ranbaxy (circa 2007), and trained/mentored regulatory inductees, in the US/EU generic submission process at Chugai, Ranbaxy and PPD.
Peter has significant experience in developing and executing EU & APAC filing strategies; providing a strategic project oversight on several clinical trial studies and lifecycle management programs. He has additional expertise in Joint HTA/RA advice, Global Filling Strategies including; EU Filing Strategies for accelerated programs and EU-VHP.
Peter has held key role positions at companies which include Ranbaxy, Kendle, Chugai and PPD. Peter has effective management experience at several levels leading global project teams and line management. Utilising his Regulatory experience, Peter excels in the application and execution of strategic plans with a ‘can do’ attitude.
With a Post Graduate Diploma - Regulatory Affairs, obtained at University of Cardiff (UK), matched with his industrial technical background, Peter is able to provide cross matched technical and regulatory expertise; being able to readily understand and translate the needs of the client to deliver focused and successful projects.