Regulatory Affairs Associate - secondment/fix-term contract

AstraZeneca plc; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

AstraZeneca plc in Warsaw is seeking a Regulatory Affairs Associate on a secondment/fixed-term contract through June 2027. The role supports licensing activities, document management, and regulatory submissions within a hybrid model (3+2).

You will liaise with Health Authorities, manage regulatory documentation, and collaborate with RAM to improve processes while mentoring teammates. English proficiency and project management experience are essential.

Qualifications

• Relevant qualification and/or experience in science.
• Experience in biopharmaceutical industry.
• Proficient English verbal and written.
• Project management skills.
• Experience in document management and tracking databases.

Responsibilities

• Document management and tracking of regulatory files.
• Plan, prepare and execute simple submissions.
• Interface with Health Authorities and regulatory systems.
• Order and track regulatory requirements (e.g., Certificates of Pharmaceutical Product, legal docs).
• Provide support across RAM for non-drug project roles.
• Coach and share knowledge within the RAM group.
• Contribute to process improvement.

Skills

English proficiency

Project management

Document management

Regulatory affairs knowledge

Team collaboration

Education

Science degree

Tools

Regulatory databases

Regulatory systems/tools

Job description

Role: Regulatory Affairs Associate (Secondment/fix-term contract until the end of June 2027)

Location: Warsaw

Model: hybrid 3+2

ABOUT ASTRAZENECA

At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel you're at the frontline of research but your role in changing patients' lives is critical. Our mission is ambitious, and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.

The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards.

Accountabilities/Responsibilities

• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements.
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
• Responsible for the ordering and tracking of specific regulatory requirements such as Registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation.
• Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Minimum Requirements

• Relevant qualification and/or experience in science
• Relevant experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project Management skills
• Experience in document management and tracking databases

Preferred Experience

• Some regulatory/medical/technical experience
• Knowledge of AZ business and processes
• Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools

Skills and Capabilities

• Good written and verbal communication skills
• Cultural awareness
• Proficiency with common document management tools
• Ability to work independently and as part of a team
• Continuous Improvement and knowledge sharing focused

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

Date Posted 29-Oct-2026

Closing Date 28-Oct-2026

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.