Operations Regulatory CMC to Astra Zeneca
Alten Sverige AB / Apotekarjobb / Stockholm
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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.
Minimum Requirements - 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
What we offer you
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!
As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-06-25ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-07-05
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4836973
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