Regulatory Affairs Manager / Local Safety Responsible

Tallinn, Estonia

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.

Company Offers

  • 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.

Requirements

  • 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.

Job Summary

Status:
This position has been filled
Posted:
4 years ago
Employment Type:
Full-time
Job Function:
Regulatory Affairs
Pharmacovigilance
Seniority Level:
Senior
Industry:
Medical Devices
Pharmaceutical