Regulatory Affairs Specialist

Opis posla

Adecco is a global leader in providing HR services.

Our client is Salvus, a modern regional company established in 2002 in Croatia, whose business operation is based on wholesale of medicines, medical products, nutritional supplements and cosmetics, as well as on strategic development and building of successful, renown and innovative brands.
For their office in Donja Stubica, we are currently looking for:

Regulatory Affairs Specialist m/f
Location: Donja Stubica

WHAT YOU'LL DO:
• Responsibility and assurance that regulatory affairs comply with the requirements of the local organization and the GRA
• Preparation of documentation, coordination and other activities required to obtain marketing authorizations in the region in accordance with national legislation/EU legislation
• Maintenance of current marketing authorizations and data on medicines, medical devices in accordance with national legislation/EU legislation (renewal of marketing authorizations, variations, etc.)
• Preparation of information about medicines, medical devices and dietary supplements
• Responsibility for receipt and accuracy of data in marketing authorizations notification of official documents to responsible persons and responsibility for the respective storage of documents and maintenance of databases
• Cooperation with relevant functions in BHC/BCC AG (GRA, etc.), the Agency for Medicinal Products and Medical Devices and other external institutions
• Cooperation with employees within the company to inform them of all regulatory affairs and assure optimum quality of documentation
• Regulatory evaluation of marketing and sales promotional materials / activities

WHAT WE OFFER:
• Contract for an indefinite period
• Pleasant working atmosphere in dynamic & rewarding environment
• Attractive salary
• Great learning possibilities

WHAT YOU'LL NEED:
• MS in Pharmacy or other biomedical/life sciences
• 3 years of experience at relevant regulatory affairs position
• Excellent written and spoken knowledge of English language
• PC literacy (word-processing, excel spreadsheets, database applications), eCTD, NeeS
• Excellent communication skills and the ability to work in a team environment
• The ability to prioritize and handle multiple projects simultaneously, with tight deadlines

If you are looking for a career in a modern company which offers great learning possibilities and further self-improvement and your profile meets the above mentioned requirements, please send us your CV in English via application link.

Note: Please mind that only the candidates selected for further consideration will be contacted and notified about the selection process

Adecco Hrvatska d.o.o. is licensed by the Ministry of Economy, Labor and Entrepreneurship for executing mediation services in employment No. UP/I-102-02/20-03/13 since 13.02.2020.