Ewa Stankiewicz Email & Phone Number

Warsaw, Mazowieckie, Poland

Responsibility for the full range of activities and tasks in regards to registration of OTC/RX products and Food Supplements/Medical Devices/Cosmetics in Teva. Maintaining records of 500 + medicinal products and bringing to live new registrations and RX to OTC Switches.Business support in line with the marketing needs including approvals on time to enable product launch, Product Information adjustments to reflect new indications, packaging lifting and umbrella branding to refresh products appearance.Documentation updates to fulfil regulation changes that come from EU and Polish Authorities. Cooperation with Global RA Function in terms of prioritization of projects, submission of new registration dossiers and others variations that might have impact on the availability of the products.Managing the RA team in Poland. Organizing work in the RA department, setting up responsibilities and workload management, supervising processes and documentation flow, trainings and mentoring people, regulatory databases maintenance.Contacts with Authorities: URPL, NIL, GIS, GIF, representative function in Polish Associations (PASMI, PZPPF).

Warsaw, Mazowieckie, Poland

Responsibility for all regulatory activities in the company and managing the Team of regulatory department. Performing tasks to build registration procedures and updating documentation. Conducting all registration process and harmonization (upgrade) of national dossier.

Warsaw, Mazowieckie, Poland

Responsibility for preparing, coordinating and finalizing: product registrations, renewals and variations (National and European Procedures). Performing of work in line with Polish Health Authorities’ notices and request response, supplements into documentation and management of deficiency letters in any of different cases: registration, variations and renewals form. Keeping in touch and providing the correspondence with Authorities of URPL, NIL, GIF, GIS.

Jelenia Góra, Dolnośląskie, Poland

Responsibility for preparing the Quality Specification of the Finished Product for the purpose of the registration in accordance with requirements created by Laboratories: finished product, raw materials, packaging and microbiology examination and based on the Pharma Law. Creating documentation needed for national and foreign renewals that are appropriate to relevant requirements, in Polish and English. Participation in creating Research Methods requested by laboratories. Supervision, creating and accepting the technological documentation of medicines products.