Brittny Smith
Compliance & Regulatory Affairs Specialist @Cytovance Biologics
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WORK HISTORY
Compliance & Regulatory Affairs Specialist @Cytovance Biologics
Oklahoma City, OK, US
Provides expertise and support in alignment with the CDMOs regulatory compliance organizational goals and requirements regarding domestic and international regulatory compliance and regulatory compliance activities for clinical studies, Phase 1, 2, and 3 leading to commercial products in a CDMO Biotech environment and FDA regulated manufacturing facility. Provides regulatory affairs and compliance services to internal and external customers through client quality agreement execution, licensing, client regulatory submissions and regulatory request support, implementation of strategies for product lifecycle, commercial annual product quality review reporting, pharmacovigilance, audit readiness, client questionnaires, executing internal audit programs, client audit programs, regulatory agency audits & inspections to independently evaluate conformance to cGMP.
EDUCATION
University of Central Oklahoma
Bachelors, Liberal Arts
ABOUT BRITTNY SMITH
Versatile, highly motivated, results-oriented professional with extensive experience and proven track-record of managing key compliance strategies that mitigate organizational risk. Expertise in program coordination and conversion, schedule oversight, system administration, data analysis and project management. Proven ability to execute deliverables in a fast-paced environment. Excellent communication, team orientation and attention to detail. Core competencies include: Regulatory Compliance | Project Management | Data Analytics, Trending & Metrics | Regulatory Submissions | System Administration | Auditing | Management of Change | Standard Operating Procedures | Audit Readiness Programs | Contract Management | Risk Exposure Assessment | Operational Effectiveness | Remediation Strategies | EH & S
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