Regulatory Affairs Associate - FTC



Vilnius, Lithuania
Posted on Tuesday, June 11, 2024

Job Title: Regulatory Affairs Associate - Fixed term contract (FTC) for 2 years.

Introduction to Role:

Are you ready to make a significant impact in the world of pharmaceuticals? As a Regulatory Affairs Associate, you will ensure efficient and timely regulatory processes, successful product launches, and effective product lifecycle management. You will provide regulatory expertise and support across the organization, maintaining focus on patient access and safety of medicines to secure license to operate in the Baltic markets.


  • Prepare and compile Baltic regulatory submissions for assigned products/projects supporting rapid and high quality approval record submission life-cycle information in accordance with current standards and processes

  • Communicates with authorities on pending issues and changes in regulatory requirements; drives and develops key AstraZeneca specific regulatory questions and processes

  • Works in close collaboration with other team members within Baltic regulatory as well as Global Regulatory, Global Labelling group and Operations Regulatory

  • Supports management of artwork projects (lifecycle maintenance and new launches) in AstraZeneca Labelling system according to company standards for all products on the Baltic market

  • Ensures AstraZeneca practices / texts / other materials meet external requirements and AstraZeneca policies

  • Acting as a local recall deputy in Lithuania

  • Acts as deputy of Baltic Medical Information Manager

  • Ensure delivery of Medical Information activities in compliance with procedural documents, preparing local documentation where required to meet compliance/audit needs

  • Active contribution to continuous improvements within the function

Essential Skills/Experience:

  • Education in pharmacy or life science

  • A minimum 2 years’ experience in Regulatory affairs is preferable

  • Languages - good proficiency in Lithuanian and English

  • Acting decisively

  • Working in a structured and lean way

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. We are part of an inclusive and giving community, supporting each other on our journeys. We are intellectually stimulated by constant learning. There's potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities.

Date Posted


Closing Date


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.