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.
