RA Specialist

Regulatory Affairs Specialist

Currently, we are looking for an experienced and motivated RA Specialist, located in Sofia, to join our highly motivated and inspired team in Zentiva.

The Regulatory Affairs Specialist prepares and submits the documents required for granting marketing authorization of medicinal products to the regulatory authority and is also in charge of the activities related to variations and renewal of marketing authorizations already granted, contributes to the expansion of the product portfolio of the company

Responsibilities:

• Prepares and submits the necessary documents to the BDA according to the normative requirements for obtaining permits for use of medicinal products;
• Observes the deadlines established by the BDA for elimination of incompleteness and / or discrepancies in the submitted documentation for registration of the respective medicinal product;
• Prepares written notifications to the BDA for the date of placing on the market of the respective medicinal product, which has received a marketing authorization, as well as in the cases of planned or due to unforeseen circumstances suspension of the sales of medicinal products. The notifications are agreed with the Medical Director before their submission to the BDA;
• Creates, maintains and stores dossiers for each medicinal product from the company's portfolio on electronic and / or paper media;
• Creates, maintains and updates an internal databases on the status of all procedures for issuing authorizations for use of medicinal products;
• Informs in due time the Marketing and Sales Directorate for each newly registered medicinal product, as well as for the occurred changes in the brief characteristics, leaflets and packages of the medicinal products;
• Participates in meetings organized by national regulatory institutions

Profile:

• Education: "Medicine", "Pharmacy", "Biology", "Chemistry", "Molecular biology" and others similar.
• Experience in Regulatory Affairs related to Bulgarian Drug Agency - 1-2 years, it is acceptable the experience to be as a trainee
• Knowledge on the normative documentation, referring to the company activity, Regulations for the internal company labour organisation, other internal normative acts.