Management of the registration, re-registration, and certification process for pharmaceuticals;
Preparation of documents included in the registration dossier for medicines, dietary supplements, medical devices (registration, re-registration, amendments). Development of regulatory documentation, drafts of medical instructions, and packaging layouts;
Requesting and revising materials provided by manufacturers;
Submission of dossiers and samples to regulatory authorities, receipt of inquiries and approved documents;
Maintenance of an electronic archive of registration documentation.
Higher education in pharmaceutical, chemical, biological, or medical fields;
At least 2 years of work experience in a similar role within a national or international pharmaceutical company;
Fluent in Russian, Romanian, and English;
Computer skills at a proficient user level;
Ability to handle large volumes of information, classify and systematize data.
