Florian Strohmaier

- Lead Regulatory Affairs and Quality Management Department - Development of global regulatory strategies for Formycon`s projects - Coordination of health authority interactions - Ensure regulatory compliance for development activities - Supervision of preparation and review of regulatory documents - Ensure GxP compliance of outsourced activities - Establishment and continuous improvement of company-wide QM system and harmonised processes

- Development of global regulatory strategies for Formycon`s biosimilar projects - Coordination of health authority interactions and preparation of regulatory documents - Set-up and organisation of Regulatory Affairs Department

Supervison of Regulatory Product Management Group; Provision of regulatory strategy for products; Coordination of Health Authority interactions and submissions, e.g. scientific advices, pre-submission meetings and MAAs in assigned regions (e.g. EU, US, Japan, Switzerland); Review of Module 1, 2, 3, 4 and 5 documents; Management of regulatory product maintenance; Regulatory support of inlicensing/outlicensing activities as well as contract manufacturing

Provision of strategic regulatory guidance to project teams; Management of Health Authority interactions, e.g. scientific advice, pre-submission meetings and proactive management of approval procedures; Preparation and/or coordination of regulatory submissions, such as MAAs, IMPDS, INDs and briefing documents; Review and/or writing of Module 1, 2 and 3 documents and review of Module 4 and 5 documents; Interim management of Regulatory Development and Regulatory Operations Group 11/2009 - 10/2010

CMC Project Champion of Sandoz/Hexal Biosimilar Projects (Epoetin alfa Hexal/Binocrit®/Abseamed® ) and other development projects; CMC input to all subprojects, development activities, regulatory strategies, authority meetings and lifecycle activities; Preparation of Module 3 for initial submissions and variations for different countries (high regulated markets and ROW countries); Preparation of responses to authority requests, briefing documents for authority meetings and CMC documentation for CTAs

CMC input to all Hexal Biosimilar projects; Writing Module 3 and the CMC part of IMPDs; Coordination of necessary actions with CMOs mainly in the fields of process development, regulatory affairs, GMP production and minor quality control; Participation in internal/external audits; Batch Record Review and processing of complaints concerning CMOs; Organisation of production of bulk drug product for clinical trials phase I-III