Regulatory Affairs Assistant
PolyPeptide Sweden / Administratörsjobb / Malmö
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PolyPeptide Group is now looking for a new team member to join our Department of Regulatory Affairs at our site in Limhamn, Malmö. As Regulatory Affairs Assistant, you will be part of a team that is responsible for writing, compiling and submitting documentation to Health Authorities in order to seek regulatory approval for PolyPeptide's drug substances. The Department supports PolyPeptide's organization globally and work with customers and authorities in all parts of the world. As a Regulatory Affairs Assistant, you work together with our team of Regulatory Managers who are responsible for different areas of our business. Your main responsibilities are:
• Compilation and submission of electronic regulatory dossiers (eCTD) to Health Authorities
• Compiling regulatory documents
• Adjust and format documents in WORD and Excel
• Enter information into different DATA sources
• Keep track of records and status of applications
• Other common assistant duties
Qualifications:
• Excellent knowledge in Microsoft Windows, especially WORD and Excel
• IT knowledge - an ability to understand and work with different IT systems
• Fluent in English - both written and spoken
• Good in Swedish - both written and spoken
• Flexible and service- minded
• Ability to work accurately with close attention to detail
• Experience with other pharmaceutical companies and/or a science background is meritorious
Communication and interpersonal skills are essential since you will interact with both internal and external customers. You are able to work independently, but also as part of team. You are able to prioritize your own tasks and, in addition, provide support to others. PolyPeptide offers an interesting job in a successful company that is growing and we want our employees to develop with us. Please send us your application as soon as possible since we will review applications continuously. The last day to apply is October 31. If you have questions regarding this position, please contact Barbara Willkomm +4640 36 62 00. Local union representatives: Unionen or Akademikerna (PAF) 040-36 62 00 We offer a full time, permanent position with an estimated start in November. If you are interested in a part time position, this is something we can discuss.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2018-10-17ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-31
Klicka på denna länk för att göra din ansökanKontaktBarbara Willkomm
barbara.willkomm@polypeptide.comFöretagPolyPeptide Sweden
AdressPolyPeptide Sweden
Limhamnsvägen 108
21613 Malmö
KontorsadressLimhamnsvägen 108, Malmö
Jobbnummer 4407065
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