Специалист Регулаторен отдел/REGULATORY AFFAIRS SPECIALIST

Вид обява

Имате въпрос?

Свържете се с нас!

Responsibilities

  1. Registration procedures for new products.
  2. Maintain marketing authorizations through variations, marketing authorization transfers, renewals etc.
  3. Preparing and submitting documentation to establish the maximum prices for pharmaceutical products and to include them on the Positive Drug List.
  4. Knowledge of local and EU legalization and monitoring of legislation changes.
  5. Maintain contact with regulatory authorities and the partners of the company.

Requirements

  • University degree in Medicine, Pharmacy, Biology or Chemistry;
  • Willingness to work;
  • Good knowledge of English;
  • Good communication skills;
  • Computer skills: MS Office;
  • Work precisely according to procedures, rules and regulations;
  • A minimum of 1 year of experience in a similar position.

The offer

  • Excellent working environment;
  • Professional development opportunities;
  • Periodic training in the field of regulatory affairs;
  • Social package (22 days of paid annual leave, food vouchers and additional health insurance).

If you are willing to join the team, prepare a detailed CV and a motivation letter, specify contact details and send documents.