Basel, Basel, Switzerland
With over 10 years’ of experience in the pharmaceutical industry at Roche and Genentech as a regulatory professional, it is a great privilege to be working with highly talented teams dedicated to translating research into meaningful treatment outcomes for patients. In my current role, as Regulatory Program Director I am passionate about leading cross-functional teams focused on developing and registering innovative medicines. With experience across the entire lifecycle of medicinal products, from early development to pre and post registration, I have gained expertise in interacting with global Health Authorities leading to successful registrations. I am proud to be playing a role in developing therapeutic choices across a large variety of therapeutic areas. I am passionate about developing others through direct management and coaching and mentoring.
- Planned and executed feedback from global Health Authorities feedback to inform a major Phase III cardio-metabolism asset across multiple indications. - Spearheaded the regulatory input on an innovative clinical trial design to support parallel development of multiple early-phase assets in the ophthalmology franchise.
Global Regulatory responsibilities for development and registration of diverse molecules across the Roche/Genentech portfolio
Accountable for the initial Marketing Authorisation Application in the EU (Ophthalmology)
EU and International regulatory responsibilities from Phase II to initial Marketing Authorisation Neuroscience, Autoimmune Anti-infective programs. Experience with orphan medicinal products Global Regulatory responsible of a marketed virology product Member of an internal Regulatory Pediatric Expert group.
Neuroscience / Marketed Products