Regulatory Affairs

8/2020 – offen

EU Regulatory Affairs for a Cannabidiol-based medicinal product in Rare Neurological Conditions (Orphan Drug) Extension of Indication (including COMP Oral Explanation) and leading / type II variations (e.g., new Route of Administration)
Leading Scientific Advice activities on Pediatric Strategy
Regional product lead for Switzerland
Acquisition by Jazz Pharmaceuticals in May 2021

Regulatory Affairs

9/2018 – 3/2020

• Responsible for EU Regulatory Affairs for 2 highly innovative Orphan medicinal
Products in Development, mainly Gene Therapy
• Leading EMA Scientific Advice activities (EMA EUnetHTA Parallel Consultation)
• Leading interdisciplinary, multi-functional Teams on novel Regulatory Procedures (e.g. EU Orphan Drug Strategy, Gene Therapy First-in-Human, Early Scientific Advice)
• Engaging, informing and facilitating Senior Management decision making under ambitious timelines
• Close cooperation with Subject Matter Experts including Clinical and Non-Clinical Leads, Market Access, CMC, Translational Medicine and Patient Advocacy Leads
• Agency Facing Role - Correspondence and Submissions of Regulatory Affairs Deliverables for products in development
• Overseeing Clinical Trials Activities for the UK and EU

Pharmakologie, Chemie, Risikomanagement, Wissensmanagement

4/2017 – 7/2018

• Leading Regulatory Documents Generation and Submission to the European Medicines Agency, e.g. Clinical Overviews, complex Safety Variations with Safety Topic Reviews for Oncology Products, Periodic Safety Update Reports, Renewals, PASS Studies, Orphan Designation Annual Reports
• Managing cross-functional Teams with regards to regulatory strategy, timelines and deliverables in line with expectations by Senior Management
• Leading strategy and submissions of Responses to Questions for various procedures
• Providing Regulatory Leadership to European Affiliates including Switzerland
• Main Contact Point to the EMA for a blockbuster product (agency facing role)• Leading procedures on regulatory (clinical) data publishing and managing IP and data
privacy related issues
• EU Regulatory Affairs Management of Clinical Trials (Approval, Health Authority
Questions, Cooperation with several CRO’s on relevant submissions, e.g. Investigator
Brochure Updates, Protocol Amendments etc.)
• PRIME – Priority Medicines Application for an Advanced Therapy Medicinal Product
(ATMP)
• Leadership, Ownership and Responsibility for eCTD contents, full familiarity with dossier
(structure), requirements and standards
• Management of key elements on Labelling, e.g. strategy, internal decision making,
agency questions (& negotiation)
• Exposure to Scientific Advice Meetings, Briefing Book Generation and Team Preparation

Regulatory Affairs, Pharmakologie, Chemie, Wissensmanagement