Regulatory Affairs Associate
AstraZeneca

Our Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licenses 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.

Essentials for the role

• Relevant qualification and/or experience in science, administration or IT

• Relevant experience from biopharmaceutical industry, or other relevant experience

• Proficient verbal and written English

• Project Management skills

• Experience in document management and tracking databases\

• 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

Desirables for the role

• 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

Internal and External Contacts/Customers

• Lead RPM and members of the GRET and GRST

• Regulatory skill groups in ORSS, Late R&I and Late CVRM

• Other R&D functions

• Marketing Companies

• Health Authorities

• External collaboration partners

• AstraZeneca Legal

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.