Regulatory Affairs Junior Associate (M/F)

Promethera Biosciences is an international biotech company with headquarters in Belgium and US operations in North Carolina, developing innovative therapies for the treatment of liver diseases. Its proprietary cell-based technology platforms are based on mature hepatocytes and allogenic progenitor cells isolated from healthy adult human liver donors. Promethera Biosciences is today in clinical stage with HepaStem and in pre-clinical stage with H2Stem.

If you are sharing our vision of the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for inborn and acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 100 people, consider joining our fast growing company. Promethera Biosciences LLC in Durham NC is currently hiring a Quality Control Associate.

 

DESCRIPTION OF THE POSITION

  • Report directly to the Regulatory Affairs Sr. Manager (RA)
  • Be dynamic member of the RA department
  • Support Regulatory team in meetings including agenda, minutes and logistics
  • Support RA team in various activities, communications and documentation as needed, including documentation research and writing
  • Under the supervision of the RA Manager, ensure adherence to applicable requirements, accuracy, consistency, completeness of regulatory documents
  • Under the supervision of the RA Manager, participate to the editing, publishing, assembly, quality, and tracking documentation to help the planned regulatory submissions
  • Establish and maintain Regulatory documentation (submission planning tools and trackers, archive correspondence, etc)
  • Writing of Regulatory affairs SOPs
  • Promethera Biosciences is offering a good opportunity to jump into RA and to acquire global RA knowledge in a dynamic biotechnology environment

 

EDUCATION & EXPERIENCE

  • Relevant scientific knowledge
  • Ability to gathering information
  • Excellent English written and verbal communication,
  • Excellent organizational skills,
  • Flexibility, professionalism and good interpersonal skills (within the RA field and across all the departments of the Company),
  • Solution and results oriented
  • Team player who can work independently

 

QUALIFICATIONS

  • Master’s in sciences (Pharmaceutical Sciences, Life Sciences or equivalent), a PhD is a plus. A strong candidate with a relevant BSc will be considered if has some relevant industry experience
  • Strong interest for RA is mandatory
  • Interest for cell therapy is a plus
  • Basic knowledge of GXPS and/or clinical trials is a plus

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LOCATION

  • At our headquarters in Mont-Saint-Guibert  / Gosselies, Belgium

You may apply for this position by sending your CV and application letter to hr@promethera.com

Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.

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