Florian Strohmaier
Vice President Regulatory Affairs & Quality Management @Formycon AG
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WORK HISTORY
Vice President Regulatory Affairs & Quality Management @Formycon AG
Lead Regulatory Affairs and Quality Management Department - Development of global regulatory strategies for Formycon`s biosimilar projects - Coordination of health authority interactions - Ensure regulatory compliance for development activities and support the establishment of internal standards andprocesses - Supervision of preparation and review of regulatory documents (e.g. Briefing Books, IMPDs, INDs, PSPs, MAAs, BLAs)- Ensure efficient cooperation with consultants and license partners for RA and QM activities - Ensure GxP compliance of outsourced activities (GMP supply chain, GLP studies, and clinical studies) in close cooperation with individual departments - Responsible for supplier qualification, audit planning and performance - Establishment and continuous improvement of company-wide QM system and harmonised processes - Establishment and maintenance of document management system for project documentation - QM oversight of Formycon internal labs including GMP labs- Lead FDA readiness programs
EDUCATION
Rheinische Friedrich Wilhelms Universität Bonn
M.D.R.A., Master of Drug Regulatory Affairs
Fachhochschule Weihenstephan Freising
Dipl.-Ing. (FH) Biotechnologie
SKILLS
ABOUT FLORIAN STROHMAIER
15 years of experience in regulatory affairs and quality management in small and…
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