About us:
We, Clinres farmacija, are a strong and reliable partner with objective to deliver the highest quality of services to our clients in the highly demanding and extremely challenging area of clinical research, regulatory affairs and pharmacovigilance in Central & Eastern Europe.
Job position:
Regulatory Affairs Officer (m/f)
Contract type:
Permanent agreement
Key responsibilities for this role include:
- registration of medicinal products (national procedure, MRP and DCP procedure) and registration / notifications of medical devices, food supplements, cosmetics and biocides
- post-registration regulatory activities (variations, renewals, MA transfer, etc.) for medicinal products, medical devices, food supplements, cosmetics and biocides
- expert translations of Summary of Product Characteristics, Package Leaflet, Instructions for use and labeling, and translations of other documentation on medicinal products, medical devices, food supplements, cosmetics and biocides
- activities related to placing medicinal products and medical devices on the list of medicinal products or orthopedic aids
- obtaining approvals for import of medicinal products, and approvals for exemption from labeling and Package Leaflet
- participation in the preparation of standard operating procedures (SOPs) for regulatory affairs
- continuous monitoring of national and EU regulations in the field of regulatory affairs
The minimum qualifications for this role are:
- university degree – medicine, pharmacy, medical biochemistry, dentistry, veterinary medicine
- minimum 2 years of work experience in the field of regulatory affairs
- excellent knowledge of English and Croatian language
- active knowledge of MS Office
- reliability and responsible approach to work
- orientation to details and precision
- excellent communication and organizational skills and flexibility in work
Application:
Please fill in the form below or send your application to the e-mail address info@clinres-farmacija.hr.
