Consultant as Regulatory CMC Associate for AstraZeneca
Poolia Stockholm AB / Kemiingenjörsjobb / Södertälje
2017-12-15
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➡️ Klicka här för den senare publicerade platsannonsen "Consultant as Regulatory CMC Associate for AstraZeneca" (publicerad 2018-04-09) ⬅️
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hela Sverige 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 the duration of twelve months. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible. Application deadline is 15th January.
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 serious 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.
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
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.
Minimum Requirements - Education and Experience
• Degree in Chemistry or 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
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-12-15ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-01-15
Ange följande referens när du ansöker: 48799
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 3856214
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