A new career opportunity became available for an experienced Regulatory Affairs Manager to join a leading global pharmaceutical company in Estonia. The chosen candidate will be responsible for the registration procedures of a very diverse product portfolio, including prescription medicine, consumer healthcare products and medical devices.
- An attractive compensation package with benefits (company car, health insurance, performance bonus, 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.
- Bachelor’s degree in Life Sciences or Pharmacy;
- 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;
- Familiar with adverse drug event reporting guidelines;
- Good organisational skills and ability to work independently;
- Fluency in Estonian and English, both written and spoken;
- Computer literacy (Microsoft Office tools);
- Prepared to travel locally and internationally.
Main Duties & Responsibilities
- Planning and managing regulatory submissions for new product registrations and already marketed products;
- Ensuring portfolio maintenance in compliance with national, MRP, DCP and CP procedures;
- Providing expert support to internal and external customers (health authorities, distributors, partners, etc.);
- Overseeing all Pharmacovigilance (PV) activities and ensuring Adverse Event reports are processed in an accurate and timely manner;
- Acting as the main point of contact for regulatory and safety issues;
- Reviewing labelling and promotional materials;
- Reporting to the regional DRA Director.