Regulatory Affairs Manager (f/m/d)
Core
Provide end-to-end regulatory leadership for complex client programs in CDMO manufacturing, ensuring compliant development, manufacturing, and commercialization of highly complex molecules including bioconjugates.
Role type
Manager, Regulatory Affairs (CDMO)
Builds
Regulatory strategies, submissions, lifecycle management, and compliant manufacturing processes for client programs.
Domain
Life Sciences / Biotechnology / Pharmaceutical Manufacturing (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, CMC strategy, GMP compliance, Health Authority interaction, dossier preparation, change assessment, stakeholder management, project coordination
Preferred skills
Experience in QC/QA/Program Management, Small Molecules/Conjugates technology, English/German language proficiency, TrackWise/LIMS/Veeva systems
Technologies
TrackWise, LIMS, Documentum, Veeva
Responsibilities
Lead end-to-end regulatory activities for assigned client programs; Coordinate regulatory workstreams across internal functions and global networks; Ensure efficient execution of submissions and lifecycle management; Act as primary regulatory interface for customers; Support inspection readiness and compliance standards.
Seniority
Manager, hands-on IC