Regulatory Affairs Specialist

Regulatory Affairs Specialist Biotrade Cosmeceuticals Sofia, Bulgaria Due to our continuous growth, we are looking for a responsible and experienced professional to join our team as a Regulatory Affairs Specialist. Key responsibilities: Preparation and maintenance of regulatory documentation for cosmetic products; Preparation of the PIF and monitoring of compliance with the applicable legislation; Preparation of documentation for notification and registration of products in Bulgaria, the EU and third countries; Review and approval of labels, promotional materials and product claims; Communication with competent authorities, laboratories, suppliers and partners; Monitoring changes in the regulatory framework and assessing their impact on the product portfolio; Participation in internal and external audits; Maintenance of regulatory databases and of the documentation archive. Requirements: University degree in Pharmacy, Chemistry, Biotechnology or a related field; Previous experience in regulatory affairs; Experience with regulations for cosmetics, medical devices, medicinal products or food supplements is an advantage; Knowledge of Regulation (EC) No 1223/2009 on cosmetic products; Knowledge of ISO 22716 on good manufacturing practices for cosmetic products; Knowledge of Regulation (EU) 2017/745 on medical devices (MDR); Knowledge of the legislation on food supplements and foods; Knowledge of the main requirements for registration, labelling and notification of products in the EU and third countries; Experience with technical documentation, PIF, SDS, specifications and certificates; Excellent written and spoken English; Very good computer literacy: MS Office (Word, Excel, PowerPoint, Outlook); High level of organisation and attention to detail; Analytical thinking and ability to work with regulatory texts; Responsibility and discretion when handling company documentation; Planning skills and ability to meet deadlines; Good communication skills and ability to work in a team; Initiative and drive for professional development. Apply Now