Sheldon

• Directing strategy and maintaining Technical Roadmap agreed upon with Program Manager.

• Promoting the use of Root Cause Analysis to identify why issues occurred in order to continuously improve.

• Map existing "As Is" processes and create new processes for solving business problems using requirements elicitation and data analysis.

• Led requirements gathering and vendor engagement for regulatory affairs software implementation, ensuring alignment with 21 CFR Part 11 and data integrity standards.

• Coordinated & executed requirements elicitation for D365 ERP system implementation.

• Coordinated cross-functional teams to deliver submissions across the US, EU/UK, Africa, LATAM, and Asia.

• Streamlined the submission lifecycle, and efficiency of associated workflows.

• Developed real-time trackers and dashboards, giving leadership clear oversight of renewals, variations, and global filing progress.

• Led business analysis processes including

• Requirement Gathering and Solution Assessment.

• Led process improvement initiatives.

• Facilitated onboarding of Zoho Project Management software increasing team efficiency.

• Led cross-functional team collaboration.

• Established and ensured on-time agile delivery. • Collaboratively led team to exceed target service levels for defined metrics.

• Revamped data collection methods ans increased efficiency by over 50% and Accuracy over 60%.

• Completed a survey with a sample size of 4000 island-wide within a six-month deadline.

• Guided a team of surveyors and data analysts using a hybrid Project Management strategy.

• Led a cross-functional team of 5 direct and up to 14 indirect reports to complete project deliverables on time.