Antonio Regalado
VP Quality, Regulatory Affairs & Compliance | Rare Disease | FDA Strategy | NDA/IND | GxP
- Role
- Vice President of Business Alignment- Quality Assurance, Regulatory Affairs, and Compliance at Nexeos Bio
- Location
- Clifton, NJ, US
- LinkedIn followers
- 500 followers
About Antonio Regalado
Corporate Management Representative accomplished in leading teams through global strategic and tactical assurance, alignment, and remediation of the structure, processes, and procedures required for the medical device and pharmaceutical industries.Global reach director, collaboration facilitator, risk management integrator, quality systems implementer, compliance remediator.
Experience
Vice President of Business Alignment- Quality Assurance, Regulatory Affairs, and Compliance
Jun 2023 — Present
Lead regulatory strategy, quality systems, and compliance for a rare disease pharmaceutical startup advancing NTX-1024 (Gleceparin) through late-stage clinical development. Architect FDA designation strategy including Rare Pediatric Disease and Orphan Drug Designation submissions, and drive SPA/SAP regulatory planning for a Phase 3 pivotal trial. Oversee CMC regulatory strategy, CDMO selection and qualification, and GMP manufacturing readiness. Drive cross-functional alignment across clinical, CMC, and regulatory operations in a resource-constrained, high-urgency environment.
Education
Ramapo College of New Jersey
Bachelor of Arts (B.A.), History and Creative Writing
2009 — 2013
Skills
- Event Planning
- Powerpoint
- Microsoft Excel
- Higher Education
- Photoshop
- Microsoft Office
- Research
- Community Outreach
- Statistics
- Social Networking
- Teamwork
- Editing
- Social Media
- Public Speaking
- Student Affairs
- Teaching
- Time Management
- Microsoft Word
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