Regulatory Affairs Associate

Role: Regulatory Affairs Associate (RAA)
Location: Warsaw

Model: hybrid 32

ABOUT ASTRAZENECA
At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel youre 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

Internal and External Contacts/Customers

Lead RPM and members of the GRET and GRST

Regulatory skill group in CGT

Marketing Companies

Health Authorities

External collaboration partners

AstraZeneca Legal

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant 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.