Alicia Ronda
Wyoming
Summary
Conscientious Regulatory Affairs Associate known for high productivity levels and efficient task completion. Specialize in regulatory submission strategies, compliance management, and documentation accuracy. Excel in complex problem-solving, strategic planning, and effective communication with stakeholders to ensure alignment with regulatory standards.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Associate
The START Center for Cancer Care
Grand Rapids
04.2025 - Current
- Prepared regulatory submissions for clinical trials and product approvals.
- Reviewed research documents to ensure compliance with regulatory standards and guidelines.
- Maintained accurate records of regulatory activities and submission timelines.
- Supported audits by organizing documentation and responding to inquiries promptly.
Regulatory Affairs Assistant
The START Center for Cancer Care
Grand Rapids
07.2023 - 04.2025
- Maintain Investigator Site File for all active studies
- Process, reviewed, and filed INDSRs, SAEs, and DSURs for all studies
- Cultivate professional relationships with CRAs and serve as the main point of contact for onsite and remote monitoring visits
- Maintain laboratory certifications and normal ranges for laboratories listed on FDA 1572 forms for all studies
- Maintain and file protocol specific and EDC training documentation in the ISF
Education
Certificate of Massage Therapy -
Everest Institute
Grand Rapids, MI10-2010
Skills
- Time management
- Clinical trial compliance
- Effective communication
- Preparing regulatory submissions
- Documentation management
- Regulatory standards knowledge
Timeline
Regulatory Affairs Associate
The START Center for Cancer Care
04.2025 - Current
Regulatory Affairs Assistant
The START Center for Cancer Care
07.2023 - 04.2025
Certificate of Massage Therapy -
Everest Institute