CMC Regulatory Affairs Associate

Are you passionate about the application of science to deliver life changing medicines?

Join AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate to join us on a permanent basis in either Gärtuna or Gothenburg, Sweden.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.

We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We handle the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products' throughout the commercial lifecycle; including marketing Authoring Applications (MAAs) and all post approval activities maximising the value of business critical Supply Chain changes to the AZ organisation by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives.

As a CMC RA Associate you are responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing and Control (CMC) documentation required for submissions to support both original marketing applications and maintenance of existing licenses for marketed products including post approval submissions. As part of a dynamic team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate. The role holder will ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to updates of policy and processes as appropriate.

You will interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination as well as contribute to the development and improvement of related business processes and ensure the learning from your own projects are shared with other co-workers/within the function. Additionally you will:

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Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
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Support and delivery of submission ready packages to agreed timelines and management of information required.

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Be responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
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Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
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Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
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Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
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Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.

Minimum Qualifications:

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Bachelor's degree in a scientific subject area or equivalent
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Team working skills
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IT Skills

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Self-motivated
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Regulatory knowledge

Desirable for the role

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Basic Knowledge of the drug development process and regulatory submissions

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Understanding of current regulatory CMC requirements
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Experience in Pharmaceutical production, regulatory affairs, quality assurance, R&D
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Basic understanding of regulations and guidance governing the manufacture of biotechnology products.
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Lean approach
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Quality Risk Management

Why AstraZeneca

Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives. We're proud of our pipeline - it's not only changing the face of our industry for good and impacting the lives of patients, it's transforming the careers of our people. We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

What's next?
Are you already imagining yourself joining us? Good, because we can't wait to hear from you!