Regulatory Affairs Associate - ORSSE

The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. 

Accountabilities

- 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 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.
- Contribute 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
- 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

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 unleash 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.

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. A place built on courage, curiosity and collaboration. We make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Apply now to be part of a team that is making a real difference in the fight against cancer!

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 authorisation and employment eligibility verification requirements.