Hamburg, Hamburg, Germany
Regulatory Affairs Manager with broad experiences in CMC life cycle management of small-molecule generics for global scope. That includes post-approval CMC variations, renewals and new submissions for a wide range of dosage forms. Project work in cross-functional teams, involving BD, R&D, QA, QC, supply and launch. Outstanding communication and interpersonal skills with ability to create and inspire long-lasting relationships and collaborations with colleagues and customers.
- CMC lead for assigned projekt development - definition and execution of regulatory strategy from development to marketing authorization - compiling, writing and reviewing regulatory dossier M1-M5 for new submission/variation/renewal EU (MRP, DCP)/nonEU - Interaction with national- and international health authorities - Coordinating regulatory activities with contract manufacturers, customers and development partners - Regulatory intelligence, i.e. monitor competitors and regulatory landscape
- CMC life cycle management of small-molecule generics for a wide range of dosage forms with global scope, except US - Cross-functional projects, involving QA, QC, supply and launch teams - Coordinating regulatory activities with customers
- PhD Thesis: B cell response and humoral memory in murine polymicrobial sepsis - Application for animal testing and communication with authorities - Deputy speaker of the graduate school GRK 840 - Lecturing and supervising diploma and MD students - Building up and supervising flow-cytometry facility - Planning, organisation and giving literature, technical, statistic and writing seminars - Associated member and deputy speaker of the graduate school GRK 840 "Host-pathogen interactions in generalized bacterial infections"