Blieskastel, Saarland, Germany
>30 years in pharmaceutical industry and innovation. Everything is possible!
Leading the development of regulatory strategies related to Liver care products and activities within Sanofi’s Consumer Healthcare Category of Digestive Wellness, as well as supporting related device and digital projects.
Leading the development of regulatory strategies related to Essentiale brand activities within Sanofi’s Consumer Healthcare Category of Digestive Health, as well as supporting selectee digital projects in the frame of Sanofi’s White Space & Connected Health activities. Stimulating exploration of innovative digital health terrains beyond the pill and aiming for personalized, holistic and 24/7 health solutions capable to support and facilitate self-management of ailments, e.g. supported by augmented reality, blockchain, chatbots, digital therapeutics, vital sign detectors, or wearables, and utilizing cutting edge analytics and algorithms powered by artificial intelligence and deep learning.
Driving innovative Rx-to-OTC (POM-to-P) switches in existing and new categories. Stimulating exploration of unknown but supportive terrains, e.g. beyond the pill, connected/collaborative healthcare, eHealth, mHealth, medical devices, sensors, telemedicine, vital sign detectors, wearables, algorithms, AI/big data.
Identifying and driving (1st-in-class) Rx-to-OTC (POM-to-P) switches. Organization and attendance of meetings with health authorities (in particular FDA / EMA and other EU health agencies) Expertise on regulations related to switches Preparation of strategies for switching internal and external candidates Review, compilation and submission of switch dossiers Collaboration with organizations supporting Rx-to-OTC switches (e.g. AESGP) Due diligence - including regulatory evaluation of external registration dossiers Project leader for switch projects
Head of Department (8 direct reports), responsible for both, maintenance of existing marketing licenses of pharmaceutical products for human use and gaining of new marketing authorisations. Member in teams working on several European change initiatives of J&J pharma R&D related to MRP/DCP, variations, regulatory policy and intelligence, and initiatives of the local leadership team. In cooperation with Market Access, attendance at meetings of the LAWG (Local Area Working Group), a working group of international, research-oriented pharma companies (mainly associated with US PhRMA).
Management of a local Regulatory Affairs CMC (Technical Writing Biotech) group (6 direct reports). Responsible for CMC Change Management. Member of Interpharma´s (Swiss pharma R&D trade association) regulatory coordination and quality experience exchange groups. Support of J&J (CENTOCOR, J&J Cross Pharma, Global Pharmaceutical Supply Group) Biotech Project Portfolio through membership of tech. transfer steering committee and associated project teams. Support of worldwide submissions related to Phase III clinical and marketing authorizations of commercial products. Ensuring the quality of CMC regulatory submissions and responses to health authority queries. Sign-off of CMC Documentation and Expert Reports/Opinions/Statements. Recruitment, leadership, resource, financial and personnel management of cost centres. Supervision and coordination of the writing of CMC documentation. Supporting product development and lify cycle management of 12 biotech pharma products including REMICADE (R), EPREX (R), STELARA (R) and SIMPONI (R). Local expert on EU biosimilar regulations.
Management of a local and European Regulatory Affairs CMC (Technical Writing) groups in Switzerland and Belgium (9 direct reports). Responsible for chem.-pharm. Dossiers. In 2001, establishment of a European Dossier Mngmt Group with offices in Belgium and Switzerland in support of the consolidation of J&J Pharmaceutial R&D and the Janssen Research Foundation. In 2002, ad interim head of local J&J PRD and member of Cilag board (staff of ~ 40 in functions of AD, PD, CSU, QA, IT and technical registration), establishing new vision/mission and leading the integration of AD/PD in Centocor biotech R&D. Support of J&J and Janssen-Cilag Project and Product Portfolio - clinical and post-marketing. Support of worldwide submissions related to Phase III clinical and marketing authorizations of commercial products. Ensuring the quality of CMC regulatory submissions and responses to health authority queries. Sign-off of CMC Documentation and Expert Reports/Opinions/Statements. Recruitment, leadership, resource, financial and personnel management of cost centres. Supervision and coordination of the writing of CMC documentation.