Regulatory CMC Associate
Modis Sweden AB / Kemiingenjörsjobb / Södertälje
2018-04-09
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hela Sverige Modis Life Science is looking for a Regulatory CMC Associate, CMC Regulatory Compliance & Stability, Operations Quality Administrator to AstraZeneca in Södertälje. The consultant assignment will start in June 2018.
Welcome with your application no later than April 14h!
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. Here, employees are empowered to express diverse perspectives - and are made to feel valued and energized for their ideas and creativity.
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
What do we offer?
Modis Life Science is a specialized Business Line within Adecco group. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Modis Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you can share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position contact Anders Olsson,
anders.olsson@modis.seMore information:
Applications will be reviewed continuously.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-04-09ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-16
Klicka på denna länk för att göra din ansökanKontaktAnders Olsson Anders.Olsson@Modis.se
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4070347
Observera att sista ansökningsdag har passerat.