CMC Regulatory Affairs Associate
Are you passionate about the application of science to deliver life changing medicines?
Join, 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 Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associates to join us on a permanent basis in Gothenburg Sweden, Gärtuna, Sweden or Macclesfield, UK.
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) regulatory contributions required for clinical, marketing or 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:
·Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
·Support delivery of submission ready packages to agreed timelines and management of information required.
·Be responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
·Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
·Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
·Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
·Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
Essential for the role
·Foundational/Associate degree in Science, Regulatory Sciences or Pharmacy
·Team working skills
Desirable for the role
·Bachelor's degree in Science, Regulatory Sciences or Pharmacy
·Basic Knowledge of the drug development process and regulatory submissions
·Understanding of current regulatory CMC requirements
·Experience in Pharmaceutical production, regulatory affairs, quality assurance, R&D
·Basic understanding of regulations and guidance governing the manufacture of biotechnology products.
·Quality Risk Management
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.
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you! Please apply as soon as possible but no later than 28th September.
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 authorization and employment eligibility verification requirements.