CMC Regulatory Affairs Associate - AstraZeneca
Qrios Minds AB / Kemiingenjörsjobb / Stockholm
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hela Sverige QRIOS Life Science is now looking for a CMC Regulatory Affairs Associate for a consulting assignment at AstraZeneca in Södertälje.
About the CMC section:
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.
About the position
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.
Responsibilities
• 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.
Your profile
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
About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you're looking for a world of exciting assignments and new contacts, you'll like being a consultant.
About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world's leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2024-01-05
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "976".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Qrios Minds AB (org.nr 556599-5999),
http://www.qrios.se/ Arbetsplats Qrios Life Science & Engineering AB
Kontakt Hanna Peterson
hanna.peterson@qrios.se Jobbnummer 8355842
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