Regulatory Affairs Manager, Baltics

A global consulting company specialising in regulatory services for the pharmaceutical companies is expanding its operations in the Baltic States and is looking for an experienced (Senior) Regulatory Affairs Manager to establish and lead the local team.

Job Description

  • Status

    Position has been filled

  • Posted

    6 years ago

  • Employment Type

    • Permanent (Full-time)

  • Function

    • Regulatory Affairs

  • Industry

    • Pharmaceuticals

  • Seniorities

    • Experienced
    • Manager

  • Locations

    • Riga, Latvia
    • Vilnius, Lithuania

  • Eligibility

    • EU/EEA/EFTA citizenship or a current permit to work and reside in Latvia/Lithuania.

  • Recruiter

Company Offers

  • An attractive compensation package with benefits;
  • A new challenge and prospects of career progression within a growing company;
  • A high level of responsibility and independence;
  • A flexible work schedule and environment (possibility to work from home).

Requirements

  • Bachelor's degree in Life Sciences or Pharmacy;
  • At least 8-10 years of experience working in Drug Regulatory Affairs, backed by operational management or leadership role;
  • Solid knowledge of the local and EU legal regulations related to registrations of medical products;
  • Familiarity with labelling and artwork management in the Baltics;
  • Good organisational skills and ability to work independently;
  • Fluency in Lithuanian/Latvian and English, both written and spoken;
  • Computer literacy (Microsoft Office tools);
  • Preparedness to travel locally and internationally.

Main Duties & Responsibilities

  • Planning and managing regulatory submissions for new or already marketed product registrations;
  • 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.);
  • Reviewing national documents, labelling texts and artwork;
  • Acting as the main point of contact for regulatory issues;
  • Reporting to the regional director.