CMC Regulatory Affairs Associate - AstraZeneca
Logent AB / Kemistjobb / Södertälje
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Nykvarn,
Huddinge,
Sundbyberg,
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hela Sverige We at Logent Staffing are currently seeking a CMC Regulatory Affairs Associate for an assignment at AstraZeneca. This is a consultancy position where you will be employed by Logent but work directly at the client's site, in this case, AstraZeneca.
Job Description
Assists with global/regional tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Fluent with submission compilation, publishing and approval information processes and tools. Seeks opportunities and develops "rapport" with immediate colleagues to formulate relationships within the organisation. Supports the Regulatory team in all the activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures. Supports the Regulatory Director/regulatory team in all activities related to budget monitoring and control.
Hiring Requirements
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.
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
IT Skills
Self-motivated
Regulatory knowledge
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.
Lean approach
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.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-01-05
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Logent AB (org.nr 556634-4429),
http://www.logent.se Arbetsplats Logent
Jobbnummer 8355874
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