CATEGORY & LOCATION
Regulatory Affairs JOBS - Richmond, VA

Clinical Quality Manager Richmond, VA

Category: Regulatory Affairs
addition, this role will conduct quality system gap assessments to evaluate clinical operations quality systems for conformance to requirements and then assist in the development and tracking of gap remediation plans. Specific accountabilities include: • Leading Clinical Quality Management Reviews (summarizing quality audits, deviations and CAPA trends for Altria leadership and our Clinical Ope
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Medical Writer Richmond, VA

Category: Regulatory Affairs
xperts (SME) to gather, organize and present scientific information on new products for regulatory applications and submissions primarily to the Food and Drug Administration (FDA). * Assessing data on products and processes for regulatory applications and submissions, primarily to the FDA. * Developing clear and effective communications of scientific information received from SMEs and literature s
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Quality Compliance Auditor Richmond, VA

Category: Regulatory Affairs
ncumbent will be required to support FDA inspection activities and develop compliance assessments and trend analysis of emerging risk areas and formulating escalation communications to management. The incumbent will be expected to apply a broad based knowledge of quality operations and FDA related regulatory compliance in order to assist in the development, execution and assessment of proposed co
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Regulatory Program Leader - Postmarket Surveillance and Advocacy Richmond, VA

Category: Regulatory Affairs
ced risk products. (Learn more at Altria.com) Our approach to regulatory advocacy relies on deep scientific expertise, understanding of consumer and effective engagement and collaboration with regulatory agencies. Fueled by our strong core tobacco business, we've been concentrating on new product platforms. These include oral nicotine containing products, E-Vapor??, and heated tobacco products?.
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Regulatory Program Leaders - Science & Advocacy Richmond, VA

Category: Regulatory Affairs
ective engagement and collaboration with regulatory agencies. Fueled by our strong core tobacco business, we've been concentrating on new product platforms. These include oral nicotine containing products, E-Vapor??, and heated tobacco products.? We believe these platforms have potential to drive adult smoker conversion. We can only compete in the marketplace with products authorized by the FDA a
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SAS Programmer Richmond, VA

Category: Regulatory Affairs
atistical analysis plan * Reviewing TFLs (tables, figures and listings). Conducting SAS programming and analysis to verify key tables and figures * Reviewing and approving Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets and related documents from contract research organizations (CROs) * Creating SAS datasets for in-house post-hoc statistical analyses, using SAS data step
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