Regulatory Affairs Associate - CVRM

Are you passionate about science and have experience within regulatory affairs? Do you want to be part of a cross functional and global team, applying your administrative skills in a science focused environment and grow your expertise within Regulatory Affairs Management? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic (CVRM) diseases!

AstraZeneca's pipeline of innovative medicines is consistently growing within CVRM. Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.

We are more than 65.000 people in over 100 countries in AstraZeneca. Our aim is simply to positively impact lives together. Using the power of science and innovation, our people to improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments.

We are now offering an exciting opportunity for a talented and highly motivated individual to join our Regulatory Affairs Management team within the CVRM therapeutic areas as Regulatory Affairs Associate (RAA). This role is based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden.



What you'll do

The Regulatory Affairs Associate is a specialist providing regulatory specific administrative support to the Global Regulatory project team to ensure the delivery of business objectives.

In your role, you will assist other members of Regulatory Affairs Management and the Global Regulatory project teams in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The CVRM Regulatory Affairs Management group sits within the AstraZeneca Late-Stage Development CVRM organisation and is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management and strong leadership.



Your main accountabilities/responsibilities:

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Document and records management including uploading and tracking regulatory files and maintaining systems according to established AstraZeneca procedures and regulatory requirements
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Support the product registration and maintenance of designated product applications in accordance with AstraZeneca standards of regulatory compliance e.g. planning, preparing and executing simple submissions, assisting with the preparation and planning of regulatory dispatches.
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Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. co-ordination & logistics for HA meetings, management of HA fees, receipt of incoming HA correspondence, ordering EudraCT number, EudraLink support, use of Health Authority portals.
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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
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Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
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Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group
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Contribute to process improvement



Essential requirements

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At least one year's experience of work in a Regulatory department within the Pharmaceutical Industry
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Relevant qualification and/or experience in science, administration or IT
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Project Management skills, project planning and organizational skills
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Good written and verbal communication skills
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Proficient verbal and written English
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Interpersonal skills, cultural awareness and stakeholder management and networking skills
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Good IT/IS skills, comfortable in using and learning how to use IT systems
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Expertise in document management systems such as ANGEL CARA and Veeva Vault



It is an advantage if you have knowledge and experience of:

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AZ business and processes including knowledge of AZ submission, compilation, publishing and approval processes and standards
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Experience of using submission planning and submissions tracking tools





So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! Welcome with your application (CV and cover letter) no later than 30 September, 2021.

We will review the applications continuously so please apply as soon as possible.