The main responsibility of Regulatory Affairs Specialist is to achieve timely registration and renewal of assigned products (original and improved generic drugs, dietary supplements and medical devices) that are marketed by Avacare Health International in CIS countries (major markets Kazakhstan, Uzbekistan, Ukraine);
Documents preparation for registration, re-registration and making amendments to registration documentation on pharmaceuticals and other products in CIS core markets in accordance with current local regulatory requirements;
Effective cooperation and communication with agencies for registration of pharmaceuticals, dietary supplements and medical devices regarding pre-submission strategies, requirements, or clarification and follow-up of submissions under review;
Active communication with Regulatory Affairs Departments of Avacare Health International partners and suppliers, business correspondence, participation in international business negotiations;
Management of translations of master dossiers, reviews and controls quality of the translations;
Preparation of the specific documents and answers to the questions addressed by regulatory agencies ;
Development of packages for products (outer cartoon boxes, inserts, and labels);
Analysis a local legislation, monitors current regulatory requirements and reports;
Documents preparation and support of registrations/re-registrations in CIS countries;
Knowledge of industry specific English is a must. Russian is a must. Ukrainian, Kazakh, Uzbek is a plus.
Vacancy is based in Mauritius. Position is 1 year contract re-newable.
Assistance with the ticket and one month accomodations. Medical insurance.