Stephen Brokx
Associate Principal Regulatory Writer at Certara
Based in York, Canada
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Seniority
Director
Department
Writing/Editing
Location
York
Industry
Business Consulting and Services
Company size
1.4K
Contact information
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s•••••••@certara.com
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Background
About Stephen Brokx
Biopharmaceutical product development and GMP professional with a broad set of proficiencies, including- Pharmaceutical and biopharmaceutical analytical development, qualification, validation and QC analysis - Team leadership and project management - CMC Regulatory: writing of module 3 of CTD, NDA & IND submissions, answering regulatory questions (IR, LOQ), document management - Coordination of multiple Contract Research and Manufacturing Organizations to execute deliverables - Protein and peptide chromatography, RP-HPLC, structure and function analysis
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