Dr. Gunther Milch
Angestellt, Regulatory Affairs Coordinator, Catalent Germany Eberbach GmbH
Eberbach, Deutschland
Werdegang
Berufserfahrung von Gunther Milch
Bis heute 12 Jahre und 2 Monate, seit Mai 2012
Regulatory Affairs Coordinator
Catalent Germany Eberbach GmbH
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
6 Jahre und 7 Monate, Okt. 2005 - Apr. 2012
Regulatory Affairs Manager
R.P. Scherer GmbH & Co. KG
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.
Ausbildung von Gunther Milch
Chemie
Universität Kaiserslautern
Sprachen
Deutsch
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