Job expirat
??? Preparation of the medicinal products regulatory documentation (first registration, renewal, variations) for submission to the competent authorities
??? Translation and maintenance up to date of the SPC, leaflet and labelling of the medicinal products medical devices, food supplements, oral healthcare products
??? Submission of the PSURs
??? Reviews and update preclinic and clinic materials and ensures that these materials meet local regulatory requirements and codes of practice
??? Submission to the NMA and approval of the promo materials for medicinal products
??? Maintenance of the regulatory database
??? Legislation monitoring (knowledge of national and European legislation)
??? Communication and collaboration with Logistic and Marketing Departments to achieve the company interests from commercial point of view
??? Communication and collaboration with Regional Regulatory Department
??? Communication and collaboration with national authorities (National Medicines Agency, Ministry of Health)
??? Mandatory university degree in: medicine
??? Minimum 2 years regulatory experience
??? Fluent English
??? Good PC skills (MS Office)
??? Communication skills, detailed oriented, highly organized and responsible person
Companie nationala, important producator si distribuitor de produse farmaceutice si suplimente nutritive, activa pe piata de profil incepind cu 2001, aflata in continua expansiune.
