Regulatory Affairs Associate – Respiratory and Immunology

Regulatory Affairs Associate Respiratory and Immunology

Location: Warsaw hybrid work (3 days per week from office)

Are you passionate about science and have or would like to get experience within regulatory affairs Do you want to be part of a cross functional and global team applying your administrative skills in a science focused environment and grow your expertise within Regulatory Affairs Management Then join us to discover future treatments of Respiratory and Immunology (R&I) diseases!

At AstraZeneca we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients lives together as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function were focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore learn and develop across all regulatory roles and levels with the aspiration to make AstraZeneca the place to build your career in Regulatory.

We are now looking for a new members to join our Regulatory Affairs Management team within the R&I therapeutic areas in the roles as Regulatory Affairs Associate (RAA).

The Regulatory Affairs Associate assists other members of Regulatory Affairs Management group in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards. This role is crucial in ensuring compliance and supporting the regulatory processes that enable our innovative treatments to reach patients.

The R&I Regulatory Affairs Management group is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise efficient project management and strong leadership.

Your main accountabilities/responsibilities:

Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements

Working with setting up clinical trials submissions in Electronic Regulatory Vault (ERV)

Planning preparing and executing simple submissions for clinical trial applications 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. working in Clinical trial Information Management System (CTIS)

Responsible for the ordering and tracking of specific regulatory requirements such as Legal documentation e.g. Letters of Authorisation Powers of Attorney

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

Do you have the essential qualifications for this role

Excellent written and verbal communication skills

Organized with project management skills

Experience in document management and tracking databases

Interest in exploring how AI and digital tools can support everyday work activities

Cultural awareness

Proficiency with common document management tools

Ability to work independently and as part of a team

It is an advantage if you have knowledge and experience of:

Relevant qualification and/or experience in science administration or IT

1-6 years of relevant experience from biopharmaceutical industry or other relevant experience

Application of AI tools in a working environment

Experience with Veeva Vault

Some regulatory/medical/technical experience

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.