Regulatory Affairs Specialist

Vilnius, Lithuania

Job Description

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

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 Life Sciences;
  • At least 2-3 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 Lithuanian 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 legacy product registrations (MAAs, variations and renewals);
  • Ensuring portfolio maintenance in compliance with CP (mainly), MRP, DCP and a few NP procedures;
  • Implementing and reviewing labelling across assigned countries;
  • 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 Baltic cluster when applicable;
  • Reporting to the regional DRA Director.

Job Summary

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