Regulatory Affairs Specialist, Baltics

Tallinn, Estonia

A global pharmaceutical company is looking for an experienced Regulatory Affairs Specialist to join its Nordic-Baltic team in Estonia. The chosen candidate will be responsible for the registration procedures of company’s speciality care and hospital products in the Baltic States.

Company Offers

  • An attractive compensation package with benefits (performance bonus, health insurance, etc.);
  • A new challenge and prospects of career progression within a growing company;
  • A high level of responsibility and independence;
  • A supportive and friendly working environment.

Requirements

  • University degree in Pharmacy or Life Sciences;
  • At least 4-5 years experience working in Drug Regulatory Affairs role;
  • Solid knowledge of the local and EU legal regulations related to registrations of medical products;
  • Good organisational skills and ability to work independently;
  • Fluency in Estonian and English, both written and spoken. Knowledge of Russian would be an advantage;
  • Computer literacy (Microsoft Office tools);
  • Prepared to travel locally and internationally.

Main Duties & Responsibilities

  • Planning and managing regulatory submissions of new and already marketed product registrations;
  • Ensuring portfolio maintenance in compliance with national, MRP, DCP and CP procedures;
  • Implementing and reviewing labelling across the Baltics;
  • Providing regulatory support to internal and external customers (health authorities, distributors, partners, medical team, etc.) and assisting tender management and reimbursement process;
  • Supporting QA/Compliance team in drafting and monitoring of company’s SOPs;
  • Acting as back-up for other countries in the Nordic-Baltic cluster when applicable;
  • Reporting to the regional DRA Director.

Job Summary

Status:
This position has been filled
Posted:
9 months ago
Employment Type:
Full-time
Job Function:
Regulatory Affairs
Seniority Level:
Senior
Industry:
Pharmaceutical