Regulatory affairs associate
Dfind Science & Engineering AB / Kemistjobb / Södertälje
2015-04-02
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hela Sverige Regulatory CMC associate
On behalf of our AstraZeneca we are now looking for candidates for a 3 month consultant assignment within Regulatory Affairs. During this assignment you will have a position as Regulatory CMC Associate within Chemistry, Manufacturing and Controls (CMC) Compliance Management. You will work in teams that define and manage regulatory aspects of projects and produce CMC documentation for submission to Health Authorities worldwide.
Main duties:
• Produce and support the production of Chemistry, Manufacturing and Control (CMC) documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable.
• Coordinate assembly and / or generate documentation of submission-ready components to support lifecycle regulatory submissions.
• Update relevant electronic systems to be consistent with regulatory submissions and commitments.
• Checking and correction of data post migration of documents and regulatory status information to new IT systems.
Business: Dfind Science & Engineering
City: Södertälje
Job type: Full time
Deadline for applications: 2015-04-30 Note: Candidate selection and presentation will be done continuously.
Qualifications:
• An academic degree in Chemistry, Pharmacy or a related subject
• Experience from the pharmaceutical industry and from regulatory content authoring and tracking systems is desirable
• Excellent oral and written communication in Swedish and English
• IT Software skills
• Ability to learn and keep up to date with new and changing regulations
• Team working skills
• Good communication skills
Please send your application in English.
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
More information: Linda Nord, phone: 0733434654
e-mail:
linda.nord@proffice.seOrganization/Business description:
Proffice Life Science is the leading Nordic specialist of temporary recruitment services within the Biotech and Chemtech industries. We are able to provide our Nordic clients with highly skilled and experienced specialists from all over Europe.
All consultants, employed by Proffice, are specialists. Proffice is one of the largest and most well-renowned staffing agencies in Sweden. All consultants, hired by Proffice, have secure and permanent employment contracts with a certified staffing agency. We offer excellent benefits and personal development opportunities within a wide range of positions and industries.
Our clients expect only the best from Proffice and we expect only the best from our consultants. As you will spend your working day on our clients' premises, you will have to not only be an expert in your field, but also a flexible, independent and social member of the team. You thrive on new challenges and welcome new opportunities. If this appeals to you, we offer a stimulating job, with excellent benefits such as private medical insurance, discounted gym membership and further contributions to health care related activities.
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Publiceringsdatum2015-04-02Arbetstider och omfattningHeltid Visstid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2015-04-30
Ange följande referens när du ansöker: 200733845
Klicka på denna länk för att göra din ansökanKontaktJohanna Wagrell
johanna.wagrell@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Lunagallerian 1
15172 SÖDERTÄLJE
KontorsadressLunagallerian 1, 15172 SÖDERTÄLJE
Jobbnummer 2234340
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