Lausanne, Vaud, Switzerland
Head of Regulatory Affairs with 15 years experience in the pharmaceutical industry and Regulatory Affairs. Successful track record of multi-regional new drug development (small & large molecules, biotechnology-derived API), registrations in Europe, USA, CH & export countries. Main therapeutic areas: oncology, antiviral agents, CNS, cardiovascular and pain. Primary contact with world-wide Regulatory Authorities. Management of EU Scientific advice procedures & negociations (EMA and EU National Competent Authorities) Management of FDA meetings & communications (pre-IND, EOP1, EOP2, pre-NDA) Orphan drug designation, PIP Pre J-IND consultation with PMDA Management of EU CTAs& MAA, US IND&NDA, post Approval changes. Recruitement, training and mentoring of less senior staff.