Bea Loran Email & Phone Number | Expert drug development strategist in global clinical, non-clinical regulatory requirements with over 22 years of experience in all phases (I to IV) of drug development and post-approval in multiple therapeutic areas.. Expert knowledge of global i.e. EU, US, Canada, Japan, Australia, regulatory requirements for pre-clinical and clinical development, as well as regulatory operations, and extensive health authority interactions with worldwide regulatory agencies (FDA, EMA, PMDA, TGA, Health Canada) in early and late phase drug development. • Development of regulatory strategies all stages of NCE development and strategy for regulatory actions, submissions in US, EU, Japan, Australia, Canada • Supplemental submissions (sNDA, sWMA) related to new indication, new population, new formulation • CTA , IND, etc., preparation and strategy for regulatory agency meetings, EoP2, EMA Scientific Advice etc. • Regulatory guidance pediatric programs consultation (EU, US) PIP advice • Product labeling (initial and revisions) for investigational and marketed products

Bea Loran

Expert drug development strategist in global clinical, non-clinical regulatory requirements with ove...
New York, New York, United States

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Bea Loran’s Email bloran@nyc.rr.com

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Bea Loran’s Location New York, New York, United States

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Bea Loran’s Prior Industry Self Employed | Merck | Merck Sharp And Dohme

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Global Regulatory Strategy Lead

2019-05-01 00:00:00 - Present

Regulatory Affairs Executive

2012-01-01 00:00:00 - 2019-01-01 00:00:00

Director Regulatory Affairs Worldwide

2000-06-01 00:00:00 - 2011-06-01 00:00:00

Director, Regulatory Affairs Europe

1993-11-01 00:00:00 - 2000-05-01 00:00:00

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Bea Loran is a Expert drug development strategist in global clinical, non-clinical regulatory requirements with over 22 years of experience in all phases (I to IV) of drug development and post-approval in multiple therapeutic areas.. Expert knowledge of global i.e. EU, US, Canada, Japan, Australia, regulatory requirements for pre-clinical and clinical development, as well as regulatory operations, and extensive health authority interactions with worldwide regulatory agencies (FDA, EMA, PMDA, TGA, Health Canada) in early and late phase drug development. • Development of regulatory strategies all stages of NCE development and strategy for regulatory actions, submissions in US, EU, Japan, Australia, Canada • Supplemental submissions (sNDA, sWMA) related to new indication, new population, new formulation • CTA , IND, etc., preparation and strategy for regulatory agency meetings, EoP2, EMA Scientific Advice etc. • Regulatory guidance pediatric programs consultation (EU, US) PIP advice • Product labeling (initial and revisions) for investigational and marketed products