CMC Regulatory Affairs Manager - AstraZeneca
Qrios Minds AB / Kemiingenjörsjobb / Stockholm
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hela Sverige CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca's global supply chain. QRIOS Life Science are looking for consultant within CMC Regulatory Affairs to join AstraZenecas CMC team focused on divestment related activities located in Södertälje.
We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.
About the position
As a CMC Regulatory Affairs Manager you will manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle including keeping business wide electronic systems up to date to maintain regulatory status.
As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with stakeholders, collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated.
Your profile
Minimum Requirements - Education and Experience
• Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
• Fluently spoken and written English
• Experience in CMC Regulatory Affairs
Desirable
• Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance
Skills and Capabilities
• Understanding of Regulatory CMC dossier and requirements
• IT software and document management interest and skills, key systems Word and Veeva Vault
• Attention to details, highly organized, able to plan, progress and control tasks and own workload effectively and manage expectation of others
• Able to work with short and / or changing timelines
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• High level understanding of GMP and working in a regulated environment
• Excellent written and verbal communication skills
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 2023-12-07
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "950".
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 8290091
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