Jules Tessono
Regulatory Operations (Promotional Review & Rims) @Illumina
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WORK HISTORY
Regulatory Operations (Promotional Review & Rims) @Illumina
Led the full review and approval cycle of promotional and advertising materials within Veeva Vault PromoMats and Regulatory Information Management (RIM) systems, ensuring compliance with FDA, FTC, EMA, and other global health authority requirements.• Verified product and marketing claims against regulatory filings, approved labeling, and scientific literature; created annotated reference packages linking claims to validated data for MLR review.• Collaborated with Regulatory Affairs and Data Governance teams to ensure consistency between RIM data, labeling content, and promotional claims across product portfolios.• Maintained RIM data integrity by aligning submission metadata, product registration details, and document version control to support accurate promotional content management.• Oversaw documentation and reference archiving within Veeva RIM to support inspection readiness, traceability, and lifecycle management of regulatory promotional submissions.• Partnered cross-functionally with Medical, Legal, and Compliance teams to ensure seamless coordination of the PRC process and timely approvals in alignment with business milestones.• Developed and implemented SOPs, controlled vocabularies, and naming conventions to standardize data entry and improve RIM-PromoMats integration workflows.• Provided training for cross-functional partners on PromoMats and RIM processes, emphasizing compliant documentation, version alignment, and data quality best practices.• Supported continuous improvement initiatives to enhance submission accuracy, streamline regulatory workflows, and strengthen audit and inspection readiness.
EDUCATION
Roger Williams University
Bachelor's degree
ABOUT JULES TESSONO
Experienced Regulatory Information Management (RIM) and Promotional Review professional…
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