Valerie Mbella

Senior Director, Global Regulatory Affairs, Diagnostics Leader @Johnson & Johnson Innovative Medicine

Raleigh, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2025 — Present

Senior Director, Global Regulatory Affairs, Diagnostics Leader @Johnson & Johnson Innovative Medicine

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EDUCATION

2001 — 2003

University of Kent at Canterbury, Brussels School of International Studies

MA, International Relations

1995 — 1999

University of Mount Olive

Bachelors, Biology; Chemistry

SKILLS

ValidationGmpIso 13485Regulatory SubmissionsBiotechnologyPharmaceutical IndustrySopFdaQuality SystemMedical DevicesRegulatory AffairsCapa

ABOUT VALERIE MBELLA

Summary of QualificationsRAC (US)Certified Quality Auditor (ASQ CQA)Mid-level ManagerFirst-rate technical writing skills, particularly in respect to writing clinical study protocols, SOPs, and Regulatory SubmissionsMonitoring device trialsProven track record in quality system management and regulatory strategiesSpecialties: internal and supplier auditing, business development, metric reporting, computer validation, documentation, QSR, GXP, ISO 9001, ISO 13485, LIMS, lotus notes, management, microsoft access, microsoft excel, microsoft outlook, microsoft powerpoint, NMR, SDLC, IQ/OQ/PQ, quality, quality control, training, validation, ISI Publisher (Regulatory Publishing)

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Valerie Mbella — Senior Director, Global Regulatory Affairs, Diagnostics Leader at Johnson & Johnson Innovative Medicine in Raleigh, NC, US | Unifers