Mark Gauthier
Senior Director, Regulatory Science at Voisin Consulting Life Sciences (VCLS)
- Role
- Senior Director, Regulatory Science at VCLS (Voisin Consulting Life Sciences)
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
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.
Experience
Senior Director, Regulatory Science
VCLS (Voisin Consulting Life Sciences)
Aug 2018 — Present · Seattle, WA, US
Education
Ferris State University
AAS, Industrial Chemistry Technology
Northeastern Illinois University
BS, biology
Skills
- 21 Cfr Part 11
- Life Sciences
- Clinical Development
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Affairs
- Lifesciences
- Pharmaceutical Industry
- Sop
- Fda
- Change Control
- Standard Operating Procedure (Sop)
- Good Clinical Practice (Gcp)
- Immunology
- Ctms
- Gmp
- U.s. Food and Drug Administration (Fda)
- Biotechnology
- Drug Discovery
- Oncology
- Regulatory Requirements
- Ind
- Medical Devices
- Capa
- Technology Transfer
- Ectd
- Cellular & Gene Therapy
- Clinical Trials
- Validation
- Regulatory Submissions
- Good Laboratory Practice (Glp)
- Glp
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