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).

Regulatory Affairs Specialist CEE (m/f)

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

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

The minimum base salary for this position is EUR 50.000,00 per year. According to your qualifications and professional experience the salary can be higher. The company also offers attractive additional fringe benefits.

Please address your application (CV, motivational letter, certificates) to Mag. Monika Kail, [email protected], +43 676 314 92 94