Maggie McLoughlin

Regulatory Affairs Manager @Syncromune®

Fort Lauderdale, FL, US

Secured Fast Track Designation for SV-102 by coordinating cross-functional input and submitting a strategic FDA application (granted on June 28, 2024).•Led preparation of the Preliminary Breakthrough Designation Request (PBDR), including document QC, formatting, and submission coordination; analyzed FDA feedback after denial to inform future strategy.•Supported Phase 2a Clinical Trial launch for SV-102 with regulatory readiness for multimple sites and timely “First Patient In” milestones.•Prepared and submitted Form 1571/1572 packages and cover letters for Principal Investigators (PI) site startups.•Authored and implemented regulatory SOPs; led cross-functional training sessions to drive adoption and compliance.•Managed FDA-compliant regulatory data room for due diligence and inspection readiness activities.•Led regulatory strategy discussions on Contribution of Components and facilitated biweekly team meetings to align stakeholders.•Drove regulatory deliverables for device development projects in alignment with cross-functional timelines.

Northeastern University

Master's degree

Rider University

Bachelor of Science in Business Administration

The Mary Louis Academy

Graduated with Advanced Regent Diploma