Regulatory Affairs Specialist CEE (m/f)

Nabídka pracovní pozice od 25. 4. 2024 není aktivní.

Hledaná pozice

Marketing Director, Marketing Manager, Medical Institution Manager, Regulatory Affairs Specialist, Sales Director

Místo práce:

Druh pracovního poměru: full-time

Náplň práce, pravomoci a zodpovědnosti

Our client is an international and well recognized Pharmaceutical Company in the global market. The company distributes and markets medicinal products developed in-house and in-licensed products from reputable partners. The Vienna office is responsible for the local market and the CEE region (EU and non-EU countries).

The aim of this challenging role is to support all regulatory activities in the region and to assure that the marketing authorizations do comply with current law and internal regulations.

Main tasks
- Preparing Market Authorisation Applications in the CEE region (EU and non-EU)
- Life-Cycle Management
- Compilation and maintenance of dossiers according to EU- and non-EU regulations (CTD, ND)
- Prepare, update and finalize SmPCs, PILs rsp. IFU
- Submission of PSURs
- Interacting with functional teams and external partners across the region to ensure regulatory compliance (business travel on occasion)
- Consequent monitoring of relevant legislation and guidelines
- Maintenance of in-house databases and document management systems

Požadavky na zaměstnance

Minimální požadované vzdělání: University education (Master's degree)
Pozici vyhovuje i uchazeč se vzděláním: University education (Bachelor's degree)

Znalosti

Language skills
- English - Upper intermediate (B2)
- German - Upper intermediate (B2)

Osobnostní předpoklady a dovednosti
Qualifications
- University degree in natural sciences
- Minimum 3 years of professional experience in Regulatory Affairs within an international pharmaceutical company
- Well versed with EU- and non EU-regulations, sound experience in dossier and document preparation
- Strong ability to analyse medical, scientific and technical information
- Self-responsible and self-motivated, goal driven personality
- Strives to pinpoint areas for improvement based on a positive “can do” attitude
- Excellent communication builder with ability to liaise with international teams
- Excellent German and English language skills, experience with CEE languages is beneficial
- Very good IT skills are essential

Další nabídky práce

Práce v oboru: Zdravotnictví, farmacie, sociální péče, Management

Lokality:

Zdroj nabídky: Profesia

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