Regulatory Affairs & Regulatory Operations | Clinical Research Regulatory Support & Study Start-Up
Leveraging a J.D. (passed the July 2025 Connecticut Bar Exam; 95th percentile), project management and team leadership experience, and a background in molecular & cell biology and chemistry, I integrate legal insight and scientific literacy to support pharmaceutical, biotechnology, and clinical research teams across regulatory strategy, operations, communication, clinical regulatory workflows, study start-up, and clinical-trial support.
One interdisciplinary foundation, presented through two equally important role families.
Targeting associate- and coordinator-level work involving regulatory research, document quality, submission coordination, lifecycle support, and cross-functional tracking.
Targeting documentation-focused work supporting protocol and IRB workflows, essential-document organization, study-start-up tracking, and research-compliance coordination.
The value I can bring now is grounded in work I have actually performed.
Statutory interpretation, FD&C Act research, evidence synthesis, and clear written analysis developed through legal education and public-sector legal work.
Molecular and cell biology training, Chemistry minor, iGEM laboratory records, and attention to traceability in protocols, observations, and results.
Judicial drafting, confidential records, filing review, and procedure-driven caseflow work in a high-volume court environment.
Cross-functional project reporting, audit-readiness support, stakeholder coordination, and Excel/VBA automation from aerospace program work.
My career focus is the regulated development of medicines and biologics—particularly the functions that translate scientific and legal requirements into accurate documentation, coordinated trial execution, and compliant submissions. Product regulatory affairs and clinical research regulatory operations are distinct disciplines, but both reward careful interpretation, traceable records, disciplined follow-through, and clear communication.
Credentials and experience supporting the transition.
Review the role-focused resumes or connect about an entry-level opportunity.