Regulatory affairs assistant
Dfind Science & Engineering AB / Kemistjobb / Stockholm
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hela Sverige Operations Regulatory CMC - Analyst
On behalf of AstraZeneca we are now looking for candidates for a 12 month consultant assignment within Regulatory Affairs. During this assignment you will have a position as Operations Regulatory CMC Analyst.
Operations Regulatory CMC - Analyst
Function / Team / Location:
CMC Regulatory Compliance 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 and you will work in a team of 8-10 people.
Candidate Focus & Challenge:
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.
Skills & Experience:
• IT Software skills
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
Education:
Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
Other:
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Knowledge of information and document management technology and electronic/paper publishing software
• 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
Business: Dfind Science & Engineering
City: Södertälje
Job type: Full time
Deadline for applications: 2017-01-09
More information: Julia Gonzales e-mail:
julia.gonzales@dfind.sePlease 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.
Organization/Business description:
Dfind Science & Engineering is part of Randstad, a global specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science& Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2016-12-23ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-01-09
Ange följande referens när du ansöker: 201014054
Klicka på denna länk för att göra din ansökanKontaktJulia Gonzales
julia.gonzales@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3232140
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