Regulatory Affairs Associate

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona (On-site)**

Are you passionate about **science**, **drug development**, **project management **and **regulatory affairs**?

At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative treatments for **Respiratory and Immunology (R&I) diseases.**

We are now looking for passionate colleagues to join our Regulatory Affairs Management team as **Regulatory Affairs Associates (RAA). **With us, you will specialise in providing regulatory administrative support to the Global Regulatory project teams, to ensure the delivery of business objectives.

The role is based at AstraZeneca’s new R&D site in **Barcelona, Spain**. We’re proud to be opening a hub in Barcelona, where our dynamic and collaborative team will make greater strides in bringing life-changing medicines to patients worldwide. This new hub offers exciting opportunities at the forefront of science, and the chance to be part of a team that learns and grows together. We need self-starters with the skills, determination, and passion necessary to change lives.

Our Barcelona hub has been created to achieve the next wave of breakthroughs that help us do what’s never been done before, as we expand our global footprint. Harnessing data and using the best technology solutions available allow us to positively impact science. Up to 500 R&D specialists will be hired to work at our hub in the coming two years. We want you to join us in transforming medicine and developing new treatment options that will change the lives of patients globally.

**What you’ll do**

**Your main accountabilities/responsibilities**:

- Document management including uploading and tracking regulatory files and systems according to established AstraZeneca 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 Authorities 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.

**Essential for the role**
- Relevant qualification and/or experience in science, administration, or IT.
- Relevant experience within the biopharmaceutical industry, or other relevant experience.
- Project Management skills.
- Experience in document management and tracking databases.

**Desirable for the role**
- Some regulatory/medical/technical experience.
- Some knowledge of regulatory submission, compilation, publishing and approval processes, standards, systems and tools.
- Veeva Vault experience

**So, what’s next?

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