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Triga ConsultingPosted 1 month ago

Hamburg + Homeoffice: Regulatory Affairs CMC Manager (m/w/d) - Pharma

On-siteHamburg, Hamburg, Germany

Full Time

Job Summary

Coordinate new submission applications, renewals, and variations while creating and maintaining quality-relevant CMC documents for Modules 2.3 and 3. Lead national and international regulatory procedures including MRP and DCP, guiding development projects and change-control requests through submission. Manage communications with regulatory authorities and external partners while monitoring and implementing new regulatory developments. Work 37.5 hours weekly with 40% home office flexibility. Join a successful pharma company with a broad product portfolio offering excellent training and career opportunities.

Required Qualifications

  • Ein abgeschlossenes pharmazeutisches oder naturwissenschaftliches Studium
  • Einschlägige Berufserfahrungen im Bereich Regulatory Affairs, einschließlich CMC
  • Sehr gute Deutschkenntnisse (mind. C1)
  • Erfahrung im Umgang mit Microsoft Office

Desired Qualifications

  • Eine aufgeschlossene Persönlichkeit
  • Teamfähigkeit
  • Verantwortungsbewusstsein
  • Organisationsgeschick

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