Job expirat
Regulatory Affairs Officer
International pharmaceutical company on innovative & generic medicinal products and medical devices
Job Description:
Regulatory Affairs Medical Devices
• Preparation, submission and post-approval regulatory activities in line with the national and EU regulations and company procedures for medical devices and medicinal products
• Managing the Printed Packaging Materials Workflow (translation of IFU and labeling for medical devices / SmPCs, PILs and labeling for medicinal products; draft preparation, checking, correction, revision and approval of the artworks; communication with the labeling teams of the production units)
• Maintenance of the local and global databases and archives
• Checking of the promotional materials developed by the marketing team
• Supporting other departments within the company with relevant regulatory information
• Managing regulatory activities in countries outside EU
Vigilance:
• Back-up of the National Safety Officer, in line with the applicable legislation and company procedures
• Translation of the relevant documents
• Maintenance of the local databases and archive
Quality Management
• Translation of the global company’s procedures
• Elaboration and revision of the local procedures
• Maintenance of the local databases and archives
• Participation to the local internal audits
• Regular research of the local and European legislation and assessment of the relevance for the company’s business
• Support the implementation of the company’s procedures applicable for different processes and/or departments within the organization
Reporting lines:
• Head of the Regulatory Affairs Department
Candidate Profile:
• University degree (preferable in medicine, pharmacy, biology, biochemistry, chemistry)
• Prior experience in one of the above mentioned fields and Knowledge of the local and European regulations is an advantage
• Well-organized, good planning skills, rigorous, able to priorities work and multi-tasks
• Analytical thinking and working with attention to details
• Scientific and technical analysis
• Responsible, reliable, loyal
• Advanced knowledge in English is mandatory
• PC skills are mandatory (Word, Excel, PowerPoint)
Offer
• Attractive salary
• Good career development possibilities in an international environmental
• Stimulative work environmental in a young and dynamic team
• Business laptop and mobile phone
Fresenius Kabi este lider in domeniul Nutritiei Clinice si Terapiei Volemice, atat in Europa cat si in numeroase tari din America Latina si Asia Pacific. Odata cu introducerea genericelor i.v. Fresenius Kabi se inscrie intre furnizorii cei mai importanti de pe piata farmaceutica din Statele Unite.
In intreaga lume, peste 30.000 de angajati ai companiei noastre sunt dedicati misiunii de ingrijire si imbunatatire a calitatii vietii pacientilor aflati in stare critica si a celor cu suferinte cronice cu produse inovatoare destinate atat pacientilor internati in spitale cat si celor din ambulatoriu.
In Romania, echipa Fresenius Kabi isi concentreaza toate eforturile in vederea asigurarii celei mai bune terapii si ingrijiri a pacientului critic si cronic, atat in perioada de spitalizare cat si in perioada de recuperare, pana la vindecarea deplina.
