Robert Leitner
Global Regulatory Affairs Therapeutic Area Lead Neuromuscular at Biogen
Based in Baar, Switzerland
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Seniority
Other
Department
Other
Location
Baar
Industry
Biotechnology Research
Company size
7.5K
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r•••••••@biogen.com
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Background
About Robert Leitner
Leader in Global Regulatory Affairs (RA) with 25 years of experience in the pharmaceutical industry, including Novartis Pharma (most recent), AstraZeneca, and Ipsen. Significant expertise in developing global and regional regulatory strategies with a track record of successful major approvals in various disease areas. Experience in liver, ophtha/retina, neuroscience, cardio-metabolic, gastrointestinal. Experienced in developing small molecules, biologics and gene therapies. Focused on E2E programs, starting pre-clinically through post-approval / LCM warranting the RDC (research-development-commercialization) continuum. Global scope, including Asia (China, Japan), Australia, Europe (EU, CH, UK), Canada and the US. Country organization expertise (RA Head Germany). Experienced in preparing and leading HA meetings with, e.g, EMA, FDA, PMDA, CDE, MPA, BfArM/PEI. Experienced in leading project teams in a matrix environment. Inclusive leader of direct reports based in Europe and the US.
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