Regulatory Affairs Specialist 50% in Aubonne

veröffentlicht
Kontakt
Lucie Milewski, Randstad Merck Aubonne
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Aubonne, Waadt
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
129085-39141
Kontakt
Lucie Milewski, Randstad Merck Aubonne
Telefon
058 432 61 41

Stellenbeschreibung

You have experience in regulatory affairs, in the pharmaceutical industry? You are available asap for a 50% contract for 4 months?So please have a look at this job!

Randstad is hiring for Merck in Aubonne for a temporary mission until the end of the year as:

Regulatory Affairs Specialist

In Aubonne's team, you will oversee:

  • Ensure alignment between dossiers and site GMP documentation
  • Provide deliverables for regulatory submissions, registrations, renewals, and Answers to Objections
  • Responsible for some Technical regulatory writings
  • Perform the regulatory assessment of Change controls
  • Responsible for writing and updating the site regulatory documentation
  • Provide local regulatory expertise and be the local point of contact for Global Regulatory Affairs and for Health Authorities
  • Be involved in the regulatory and implementation strategy of key projects and variations

Qualifikation

  • Expertise and knowledge in Regulatory Affairs proven by relevant educational or professional background
  • Good knowledge in biotechnological sciences and manufacturing of biologics
  • Knowledge and experience in current Good Manufacturing Practices (GMP)
  • Able to search, understand and interpret regulatory intelligence information and regulatory guidelines
  • French (C1 level) and english (B2)
  • Available asap
  • Rigourous, analytical, good writing and communication skills

Are you interested ? Please apply!