Regulatory Affairs Associate, Vaccines and Immunology Therapies

Are you passionate about science and have or would like to get 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 in the Vaccines and Immunology Therapies Area.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.



The role

We are now seeking new members to join our Regulatory Affairs Management team within the Vaccines and Immunology Therapies Area, in the roles as Regulatory Affairs Associate (RAA). This role will be based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.



What you'll do

As Regulatory Affairs Associate (RAA), you will provide 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 licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards.

The V&I Regulatory Affairs Management group sits within the AstraZeneca Late-Stage Development V&I 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 within the Pharmaceutical Industry
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Good IT/IS skills, comfortable in using and learning how to use IT systems
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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



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

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Knowledge of AZ submission, compilation, publishing and approval processes and standards
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Experience of using submission planning and submissions tracking tools
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Expertise in document management systems such as ANGEL CARA and Veeva Vault





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 17 April 2022. We will review the applications continuously so please apply as soon as possible.