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.
- 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.
- 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.