Overview
RA Associate_Croatia Jobs in Croatia at Tigermed
Title: RA Associate_Croatia
Company: Tigermed
Location: Croatia
Responsibilities
(a) Preparation and submission of registration dossier for medicinal products,
(b) Submissionof variations for medicinal products,
(c) Submission of renewal application, in line with CRO and EU regulations for medicinal
products,
(d) Monitoring and reporting of legislation for the area of work,
(e) Participation in the development of SOPs, work instructions, etc.,
(f) Participation in the development, review and revision of the SmPC and PIL,
(g) Communication with clients/contractor companies,
(h) Conducting registration procedures of medical devices, food supplements and cosmetic in Croatia and coordinating registration procedures with business partners,
(i) Communication on behalf of a client with regulatory authorities, Advising clients on the current requirements of the Croatian legislation in the area of medicinal products, medical devices, cosmetics and food supplements.
Qualification
(a) Bachelor’sndegree or above; major in pharmacy, medical science, biology, bio-science or other relevant majors;
(b) Slovenian language is mandatory; Basic written and oral communication skills in English;
(c) Regulatory experience in either human or veterinary drugs is advantage
(d) Good command in Office software like Excel, Word and PowerPoint and general computer skills;
(e) Other abilities such as Communication skillsInformation-gathering skills;
