Dr. Benjamin Vermeer

Consultant for registration strategies and responsible for registration procedure, including enrolment on the market. Responsible for module 1, preparation and regulatory release of scientific texts of CPs, DCPs, MRPs and national registrations. Responsible for communication with authorities. Due Diligence expert (modules 1-3). Medical scientific expert consulting physicians, pharmacists and patients. Medical scientific consultant for "Festbetragsregelungen" and possible OTC drugs.

Responsible for every drug registration regarding e. g. submission of variations for modules 1-5, renewals and Sunset Clause. Control of Pharmacovigilance reports. Correspondence, surveillance and compliance of authority deadlines. Correspondence with the authorities. Deputy Team Leader (six employees).

Responsible for the maintenance of European and non-European registrations (modules 2-5). Writing regulatory documents and serving as in-house regulatory expert. Responsible for maintaining up to date knowledge of regulatory affairs. Development of regulatory affairs strategies specific to quality dossiers. In charge of keeping dossiers in accordance with the internal communication and the current legal requirements and guidelines.

Immunology and Molecular Biology