Registration officer
Job position details
Registration officer
Job responsibilities
participates in the preparation and processing of registration documentation (M1 and M2) preparation of texts for SmPC, PIL, outer (in CZ, EN, SK) and cooperation in the preparation of mock-ups. Responsible for the accuracy of texts on mock-ups. Other language versions are always prepared in cooperation with the local agent. collaboration with other departments across the organization (preparation of M3-M5, assistance with problem solving). preparation of sequence (in eCTD format) and communication with regulatory authorities (new registrations, extensions, changes) monitors changes in legislation and regulations concerning medicinal products in the Czech Republic and abroad and implements them into the registration documentation. ensures submission of new national registrations or DCP registrations, being responsible for compiling the registration documentation and preparing M1, M2. collaborates in addressing comments from regulatory authorities regarding new registrations/changes of medicinal products and compiles responses across departments. monitors deadlines for registration extensions, sunset clause. communication with local agents in countries both within and outside the EU, sending necessary registration documents and ensuring submission of changes/new registrations according to the requirements of the commercial division and company management. participates in the resolution of internal documents that ensure the smooth operation of the company. ensures submission of changes within the registrations of active substances (EDQM, FDA), communication with clients. participates in the creation of corporate documentation
We require
independence in problem solving at least 2 years of experience in a similar position excellent knowledge of the Czech language (ability to proofread in Czech)
English language at B2 level
university degree with a focus on chemistry or pharmacy
We offer
working hours of 37.5 hours/week, single-shift operation employee benefits: 5 weeks of vacation, meal vouchers, contribution to pension insurance, Multisport card, Edenred card
2 days of sick leave birthday bonus workplace in Roztoky with very good transport connections from Prague immediate start or as agreed
- Vltavská 53, 252 63 Roztoky
- Hire immediately / upon agreement
Petra Nová, DiS
- I am interested in the position
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