Mark Gauthier

Senior Director, Regulatory Science @VCLS (Voisin Consulting Life Sciences)

Seattle, WA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2018 — Present

Senior Director, Regulatory Science @VCLS (Voisin Consulting Life Sciences)

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Seattle, WA, US

EDUCATION

N/A

Ferris State University

AAS, Industrial Chemistry Technology

N/A

Northeastern Illinois University

BS, biology

SKILLS

21 Cfr Part 11Life SciencesClinical DevelopmentDrug DevelopmentGcpBiopharmaceuticalsRegulatory AffairsLifesciencesPharmaceutical IndustrySopFdaChange ControlStandard Operating Procedure (Sop)Good Clinical Practice (Gcp)ImmunologyCtmsGmpU.s. Food and Drug Administration (Fda)BiotechnologyDrug DiscoveryOncologyRegulatory RequirementsIndMedical DevicesCapaTechnology TransferEctdCellular & Gene TherapyClinical TrialsValidationRegulatory SubmissionsGood Laboratory Practice (Glp)Glp

ABOUT MARK GAUTHIER

Straightforward, pragmatic professional with insight gained from extensive experience in Regulatory Affairs. Extensive FDA and EMA interaction combined with a scientific background culminates in a well-rounded experience base. I have experience working with cellular therapy, biologic and small molecule based products. Strategic thinker whose regulatory guidance and tactical advice is frequently sought by upper management. Excellent oral and written communication, ability to handle numerous projects simultaneously, and proven leadership skills.

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