Sachbearbeiter im Bereich Quality & Regulatory Affairs (w/m/d)
Core
Administrative and regulatory specialist ensuring compliance with drug and transplant laws and GMP standards for regenerative medicine products.
Role type
Regulatory Affairs & Quality Administration Specialist
Builds
Regulatory submissions, permits, and compliance documentation for cell-based therapies
Domain
Biotechnology / Regenerative Medicine / Pharmaceuticals
Deliverable
client delivery
Required skills
Regulatory document management, contract law knowledge, quality management processes, stakeholder communication, administrative precision
Preferred skills
Contract law expertise, team collaboration
Technologies
MS Office
Responsibilities
Submit applications for tissue sampling permits and modification notifications to authorities, support clients with permit-relevant changes, correspond with authorities and clinics, draft responsibility agreements with partners, maintain regulatory documents, participate in QM processes (deviations, CAPAs, changes)
