Gabor Kertes

Leading the regional (German, Austrian, Swiss, Norwegian, Sweden, Finish, Danish and Icelandic) regulatory and medical teams. Being part of the Central European leadership team, following the separation of the Home&Hygiene and Healthcare business units.

Leading the CEE regulatory & medical team and actively participates in the CEE leadership team’s work. Leading Regulatory & Medical Affairs and Pharmacovigilance Function of the Central Eastern European region. Heading a vast portfolio of market leading pharmaceutical, medical device, medical aid, cosmetic and biocide brands. Defined and executed a clear vision of a CEE one medical and regulatory affairs regional team, including a number of significant initiatives to launch NPDs and create new claims.

Leads the HU+ADR regulatory team and actively participates in the area leadership team’s work. Creates and executes Joint Venture integration plan for the whole region and consults with the local Health Authorities and Trade Associations. Ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans.

Translates the operational plan in to clear deliverable for the RA team. Creates a high performing team and looks for ways to improve the performance of the team or area. Sets engaging and clear goals and objectives for the RA team. Drives the identification, recruitment and retention of talent. Creates an environment that encourages both technical and leadership, development and rewards appropriately.

Product life cycle management, maintenance application submissions, create and file submissions, operate and archive the registration documentation, support product launch, communicate with authorities and relevant HQ departments. Reviewing and approving Technical Terms of Supply contracts. Reviewing and approving promotional and advertising materials. Coordinating the pharmacovigilance activity of the CH business and reviewing the work of the Named Safety Contacts.

Taking care of the regulatory tasks of medicinal products, food supplements and medical devices. Customer complain and quality defect handling for medical devices, food supplements (and other ad hock quality assurance projects). “Super user” of all Merck Serono medical devices in Hungary.

Specialization in neuroscience 2005 – 2008 Pain research: Diploma thesis: The role of NR2B and NR2C NMDA receptor subunits in pain sensation of genetically modified mice Department of Physiology and Neurobiology