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.

So, what’s next? 

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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.