Dr. Gunther Milch

Dual function as regulatory affairs and quality assurance manager. Integration of the local regulatory affairs department of R.P. Scherer into the global Catalent unit. Coordination of regulatory activities and ensuring of regulatory compliance. - Preparation of quality assurance agreements

CMC Management and compilation of quality dossiers. Submission of MAAs and maintenance of marketing authorizations. Coordination of regulatory activities. Ensuring of regulatory compliance with national and EU drug laws/guidelines. Local point of contact for regulatory related questions internally as well as for external customers. Contribution to local regulatory strategies and communication with health authorities. Participation in interdisciplinary project teams.