Regulatory Affairs Associate

Introduction to role:

The Regulatory Affairs Associate (RAA) plays a crucial role in assisting the Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) teams in obtaining and maintaining licenses and applications. This is done in accordance with the agreed regulatory strategy and AstraZeneca standards. Are you ready to be part of a team that turns drug development strategies into reality?

Accountabilities

• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements.
• Planning, preparing, and implementing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Be the work 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 eg. CTIS.
• 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.
• Give to process improvement.

Essential Skills/Experience

• 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

Desirable Skills/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
• Some basic knowledge/understanding of the Oncology area

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to turning our life-changing science into medicines that make a real difference for patients in need. Our innovative attitude drives us to think broadly about what it takes to prevent and treat diseases. We are a team with varied strengths that values different perspectives and skills, which helps us explore new ideas and ways of doing things. Our collaborative environment empowers us to make quick decisions and influence drug development strategies across all levels of the business.

Ready to make an impact? Apply now to join our dynamic team!

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.