Regulatory Affairs Officer - 744 - Cluj-Napoca

Regulatory Affairs Officer - 744
Cluj-Napoca
Cluj-Napoca, Cluj County, Romania

Regulatory Affairs Officer - 744

Product
Life Group is looking for a RA Associate Officer

About us

Group 10 Responsibilities

Responsibilities:

Preparation and submission of EU Marketing Authorisation Applications (Module 1, 2, 3) for Initial MAA and LCM (via DCP, MRP and NP)

Monitor and maintain
-
- date knowledge of national and European guidelines/legislation.

Ensuring compliance with all regulatory processes including MHRA and HPRA

Management of artwork generation

Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), Docu
Bridge

Building the submission backbone and handover to Reg
Ops for Publishing;

Submit Published packed via CESP/national portal.

Follow-up with the authorities and close out changes (inform affiliates etc. ), track approvals, update RA tools

Group 13 Profile

Required education :

Graduate/Master’s degree in Pharmacy

Required experience :

3 to 6 yrs experience in Regulatory Affairs

Required languages :

English

German (Fluency not required)

Informații detaliate despre oferta de muncă

Firma:	ProductLife Group
Localiția:	Cluj-Napoca Cluj-Napoca, Cluj County, Romania
Adăugat:	14. 6. 2025 Postul de muncă activ

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Regulatory Affairs Officer - 744 Cluj-Napoca

Regulatory Affairs Officer - 744Cluj-NapocaCluj-Napoca, Cluj County, Romania

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Regulatory Affairs Officer - 744
Cluj-Napoca
Cluj-Napoca, Cluj County, Romania