Regulatory Affairs Managers till AstraZeneca, Södertälje
Modis Sweden AB / Apotekarjobb / Södertälje
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hela Sverige Modis Life Science is looking for 2 Regulatory Affairs Managers to AstraZeneca in Södertälje. The consultant assignment will start as soon as possible and proceed until the end of 2018.
Welcome with your application no later than January 26th!
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 are 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 role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Main Purpose of the role:
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate
This role will be based in Södertälje, Sweden.
Accountabilities/Responsibilities
* The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post approval CMC documentation.
* As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.
* As Regulatory CMC Manager you will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance.
* The role offers opportunities to work with global networks.
Minimum Requirements - Education and Experience
Essential requirements:
* Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
* Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.
* Fluently spoken and written English and Swedish
* Project Management skills
* Excellent written and verbal communication skills
* Experience of working within a global environment.Team working skills, Flexibility, Adaptability, Influencing, Initiative
* Previous experience of working in a Regulatory CMC environment.
Preferable requirements:
* Experience of working with international markets.
* Experience of working in a LEAN environment.
* IT skills and/or knowledge of information and document management technology and electronic/paper publishing software
What do we offer?
Modis Life Science is a specialized Business Line within the 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 are able to 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.
Unfortunately, we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz,
nalin.yilmaz@adecco.seWe look forward to your application!
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-01-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-01-26
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
Nalin.Yilmaz@modis.seFöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 3911587
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