Chelsea Miller is Senior Consultant, Regulatory Affairs at The Bracken Group, specializing in the coordination, preparation, submission, and maintenance of FDA regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). She has led and supported multiple IND submissions across diverse therapeutic areas, bringing broad regulatory knowledge and strategic insight to every stage of the drug development process.
At Bracken, Chelsea serves as primary US Agent and FDA liaison for sponsors, developing, reviewing, and finalizing FDA correspondence and IND/NDA components to ensure compliance with FDA standards and guidance. She strategizes and prepares comprehensive Orphan Drug Designation applications and annual maintenance reports, and assembles FDA Meeting Requests and detailed briefing packages that drive client readiness for Type B (pre-IND and End-of-Phase) and Type C meetings, enabling informed regulatory decision-making and alignment.
Before joining Bracken, Chelsea spent six years as a Regulatory Manager at Tender Corporation, overseeing compliance for OTC drugs, Class I and Class II medical devices, and pesticide products across FDA, EPA, DOT, PMRA, and Health Canada frameworks. Clients engage Chelsea when a program needs a hands-on regulatory partner who can turn complex FDA requirements into clear, submission-ready strategy.
Coordination, preparation, and successful submission of IND, NDA, and BLA filings to the FDA, managing components, timelines, and quality across the full submission lifecycle.
Regulatory strategy and compliance support throughout drug development, ensuring filings and correspondence meet FDA standards and guidance.
Strategizing, preparing, and submitting comprehensive Orphan Drug Designation applications, plus annual maintenance reports to sustain designation status.
Preparing and submitting FDA Meeting Requests, assembling detailed briefing packages, and driving client readiness for Type B (pre-IND, End-of-Phase) and Type C meetings.
Serving as US Agent and FDA liaison for sponsors, maintaining clear communication and facilitating timely FDA interactions in support of development programs.
Developing, reviewing, and finalizing FDA correspondence, regulatory documents, and IND/NDA components to ensure regulatory compliance and readiness.
Bring Chelsea’s expertise to your next program. Let’s discuss your project.
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