małgorzata rogalińska

regulatory affairs specialist

About

Junior Regulatory Specialist at The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Country

poland

City

poland

Industry

pharmaceuticals

Skill

regulatory affairs, regulatory submissions, regulatory requirements, microsoft office, doświadczenia kliniczne, branża farmaceutyczna, gmp, farmaceutyka, sop, biologia i nauki pokrewne, weryfikacja, biotechnologia, pharmacovigilance, zarządzanie

Experience

regulatory affairs specialist

richter gedeon nyrt. / magyarország

junior regulatory specialist

valeant pharmaceuticals

2016-4 - 2017-3 · 1 yr

* Responsible for regulatory preparations, submission and managing of new registrations processes, renewals, sunset clause, and variations in national and MRP/DCP procedure (Europe, Asia, CIS) * Plans for the renewals, registration, variation, new labeling, etc. * Adjustment of SPC, PIL and information text to e.g. PRAC/PSUSA recommendations, QRD and reference product * Answer queries from management with regards to registration process * Ensure database and files system are kept up to date * Import of relevant parts of documentation to eDMS (Infotehna) * Infotehna publication (eCTD, NeeS) * Infotehna change control system

junior regulatory specialist

the office for registration of medicinal products, medical devices and biocidal products

2014-6 - 2016-3 · 1 yr 10 mos

* Department for Medicinal Products Registration, Unit for Registration of Medicinal Product in European Procedures * Responsible for registration procedure (MRP, DCP) * Liaising with European Agencies and Marketing Authorisation Holders * Working with documentation in eCTD/Nees * Participation in the evaluation of product information texts