Regulatory Affairs Specialist, Baltics
A global pharmaceutical company is looking for an experienced Regulatory Affairs Specialist to join its Nordic-Baltic team in Lithuania. 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 […]
Job Description
A global pharmaceutical company is looking for an experienced Regulatory Affairs Specialist to join its Nordic-Baltic team in Lithuania. 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 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 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.