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FDA Biologics Expert (m/w/d) (EN)

[12881]
medical device, 21 CFR, IVD

Job title: FDA Biologics Expert (m/w/d) Industry: Medizintechnik Skills: medical device,21 CFR 600,IVD Start of project: 01.06.2023 Duration of the project : 18 month Project volume: 1008 Hour(s)  Location: Bern, Schweiz Tasks: ·International registration (FDA) ·Supporting biologics license application ·Post approval reporting ·Post approval changes impacting 2 sites Qualifications: ·Background in Biology or scientific university degree in Biology ·FDA 21CFR 600/660 (Blood), BLA ·Experience with Biologics (Bllod), Vaccines or IVD ·Experience in CMC

Job title: FDA Biologics Expert (m/w/d)
Industry: Medizintechnik
Skills: medical device,21 CFR 600,IVD
Start of project: 01.06.2023
Duration of the project : 18 month
Project volume: 1008 Hour(s) 
Location: Bern, Schweiz

Tasks:

  • International registration (FDA)
  • Supporting biologics license application
  • Post approval reporting
  • Post approval changes impacting 2 sites

Qualifications:

  • Background in Biology or scientific university degree in Biology
  • FDA 21CFR 600/660 (Blood), BLA
  • Experience with Biologics (Bllod), Vaccines or IVD
  • Experience in CMC

map Bern, Schweiz date_range 01.05.2023 update Freelance

Oleksandra Moroz

phone
+41 44 274 39 00
email
o.moroz@aristo-group.ch
Direct contact

Oleksandra Moroz

Recruitment Consultant
mail o.moroz@aristo-group.ch
phone +41 44 274 39 00

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