Regulatory CMC Associate till AstraZeneca

On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Associate for a temporary consultant position. CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The role will be based in Södertälje (Gärtuna) and you will work in a team of 8-10 people.

The assignment which is full-time will start ASAP with an initial duration throughout 2019. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most severe diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace 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.

Operations Regulatory is a global function within Global Quality Supply Chain, that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the world-wide AstraZeneca supply chain.


The role
The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory documentation. You may also coordinate assembly of submission-ready documents to support lifecycle submissions.

You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.

The role will be based in Södertälje, Sweden, and you will work in a team of 8-10 people.

Education and Experience
• Degree in Chemistry, Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
• Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable

Skills and Capabilities
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Ability to work with short and/or changing timelines
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Good communication skills
• Knowledge of information and document management technology and electronic/paper publishing software
• IT software skills


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