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