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