Christine (Lightcap) Berardi, Phd Email and Phone Number
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A regulatory affairs specialist with scientific background with drug development experience for both small and large molecules from identification of lead compound through Phase 2 clinical trials, and late stage and commercial activities. Expertise spans CMC development and optimization, GxP quality support, Phase 1 clinical trial management, early and mid-stage FDA and Canadian regulatory strategy and late stage EMA regulatory strategy, with a focus on regulatory communications including electronic regulatory filings and written and face to face Agency meeting support.
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Director, Global Regulatory StrategyAbbvie Feb 2022 - PresentNorth Chicago, Illinois, Us
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Associate Principal Consultant, Clinical Development And Regulatory AffairsScilucent, Inc. Jan 2022 - Feb 2022Herndon, Virginia, Us -
Senior Consultant, Clinical Development And Regulatory AffairsScilucent, Inc. Feb 2021 - Jan 2022Herndon, Virginia, Us
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Director, Development Consulting ServicesPharmalex Nov 2018 - Feb 2021Bad Homburg, De -
Regulatory Affairs - LeadSpark Therapeutics, Inc. Jun 2017 - Oct 2018Philadelphia, Pa, UsRegulatory strategy lead for early stage ocular gene therapy programs for treatment of inherited retinal diseases in orphan populations, including pre-IND meeting preparations and IND submission requirements.Regulatory support for LUXTURNA (voretigene neparvovec) BLA and MAA activities including regulatory planning and labeling updates.Regulatory lead for collaborative Orphan Exclusivity project team supporting product development strategy for orphan designations and approval in accordance to current US and EU regulations.Regulatory lead for company's first EMA GCP inspection -
Senior ManagerPharmalex Oct 2015 - Jun 2017Bad Homburg, DeProvided US regulatory strategy for development programs spanning pre-IND through Phase 2, including preparations and attendance at multiple FDA meetings (pre-IND, Type C, Type A, EOP2, and Advisory Committee)Responsible for authoring for North American regulatory documents including Modules 1, 2, and 3 of US INDs, Health Canada CTA and CTA amendments, and routine regulatory submissions (Annual Report, DSUR), including integration with Regulatory OperationsProvided project management spanning all development departments such as manufacturing and release, regulatory submissions, clinical studies (Phase 1), and GxP compliance activities.
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ManagerPharmalex Jan 2014 - Oct 2015Bad Homburg, DeSwiftwater Group recently merged with YES Pharmaceutical Development Services to become the North American branch of YES Group LLC. In 2014, YES merged with PharmaLex to further expand its global consulting presence. YES Group LLC has adopted the name of PharmaLex Development Services (PDS) and continues to support North American development.PharmaLex is global consulting organization supporting clients in all aspects of drug development from discovery through marketing application submission including small molecules, biologics, and devices. Services offered can span both domestic (FDA) and international regulatory agencies and include expertise in non-clinical development, quality assurance and support, regulatory affairs, pharmacovigilance, and clinical operations.
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Senior Associate (Formerly Yes Group And Swiftwater Group)Pharmalex Aug 2010 - Dec 2013Bad Homburg, DeSmall consulting firm providing integrated drug development services for all stages of development- discovery through NDA. Such services include non-clinical expertise, regulatory affairs, quality assurance, toxicology, and clinical operational support.Responsible for providing biologic and small molecule CMC strategy and regulatory submission support.
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Postdoctoral AssociateFox Chase Cancer Center Jan 2009 - Aug 2010Philadelphia, Pa, UsResearch focused on the correlation of cell signaling events on early zebrafish development.Responsible for assisting graduate students in molecular biology techniques and leading research presentations.
Christine (Lightcap) Berardi, Phd Skills
Christine (Lightcap) Berardi, Phd Education Details
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Jefferson HealthBiochemistry And Molecular Biology -
Lebanon Valley CollegeBiochemistry And Molecular Biology
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Center For Professional Innovation And Education (Cfpie)Pharmaceutical Development Certified Professional (Pdcp)
Frequently Asked Questions about Christine (Lightcap) Berardi, Phd
What company does Christine (Lightcap) Berardi, Phd work for?
Christine (Lightcap) Berardi, Phd works for Abbvie
What is Christine (Lightcap) Berardi, Phd's role at the current company?
Christine (Lightcap) Berardi, Phd's current role is Director, Global Regulatory Strategy.
What is Christine (Lightcap) Berardi, Phd's email address?
Christine (Lightcap) Berardi, Phd's email address is ch****@****lex.com
What schools did Christine (Lightcap) Berardi, Phd attend?
Christine (Lightcap) Berardi, Phd attended Jefferson Health, Lebanon Valley College, Center For Professional Innovation And Education (Cfpie).
What skills is Christine (Lightcap) Berardi, Phd known for?
Christine (Lightcap) Berardi, Phd has skills like Molecular Biology, Biochemistry, Drug Development, Protein Chemistry, Cell Biology, Chemistry, Protein Purification, Regulatory Affairs, Protein Expression, Laboratory, Fda, Biotechnology.
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