Sheri Nobles
Winter Park
Summary
Experienced Regulatory Affairs Associate specializing in regulatory submission preparation and documentation oversight. Proficient in managing cross-functional team coordination to maintain compliance with industry regulations. Recognized for meticulous attention to detail and strong communication skills, contributing to successful product approvals and enhanced operational processes.
Overview
15
15
years of professional experience
Work History
Regulatory Affairs Associate
Research
Orlando
06.2025 - Current
- Assisted in preparing regulatory submissions for product approvals.
- Reviewed documentation for compliance with industry regulations and standards.
- Coordinated meetings with cross-functional teams to discuss regulatory strategies.
- Maintained accurate records of regulatory correspondence and submission timelines.
- Supported the team in conducting research on regulatory guidelines and requirements.
- Helped in compiling data for product labeling and promotional materials review.
- Participated in training sessions on regulatory processes and compliance practices.
- Monitored updates on changes to relevant laws and regulations affecting products.
- Prepared submissions for new product applications in accordance with relevant international standards.
- Compiled and maintained regulatory documentation databases and systems and explained policies, regulations and procedures.
- Enforced regulatory affairs department compliance with agency requirements.
- Coordinated activities associated with the implementation of new or revised laws, rules or regulations.
- Developed and maintained a database of regulatory information for assigned products.
- Updated in-depth trackers of approvals and submissions.
Data Entry Clerk
Research
Orlando
01.2025 - Current
- Entered and updated data in company databases accurately and efficiently.
- Verified data entry for consistency and correctness across multiple systems.
- Maintained organized records and files to support administrative tasks.
- Collaborated with team members to streamline data processing workflows.
- Responded to inquiries related to data discrepancies and resolved issues promptly.
Assistant Clinical Research Coordinator
Research
Orlando
05.2010 - Current
- Assisted in organizing research materials and resources for project teams.
- Coordinated meeting schedules and logistics for team discussions and presentations.
- Supported data collection efforts by preparing and distributing surveys to participants.
- Facilitated communication between team members to enhance collaboration on tasks.
- Monitored data collection and maintained accurate study documentation.
- Organized training sessions for staff on trial procedures and protocols.
- Reviewed research data to ensure accuracy and completeness for reporting purposes.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Monitored patient safety during clinical trials according to established guidelines.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Collected, processed and delivered specimens from trial participants.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Took vital signs and collected medical histories as part of study protocols.
Laboratory Supervisor
Research
Orlando
05.2010 - Current
- Supervised laboratory operations to ensure compliance with safety regulations.
- Managed laboratory staff and scheduled team assignments for optimal workflow.
- Developed and maintained standard operating procedures for laboratory processes.
- Conducted training sessions for new staff on equipment usage and safety protocols.
- Maintained accurate records of data collected during experiments.
- Kept equipment in good working order and facilities clean, neat and organized.
- Trained therapists on equipment and maintenance.
- Determined effective schedules by taking into consideration individual employee preferences and overall coverage needs.
- Established relationships with vendors, suppliers in order to secure competitive pricing on necessary equipment, supplies.
- Monitored laboratory inventory levels for reagents and supplies; ordered additional items as needed.
- Supervised daily operations of laboratory personnel, ensuring that all activities were completed according to established protocols.
- Assisted in the development and implementation of laboratory safety policies and procedures.
Clinical Manager
Research
Orlando
01.2023 - 05.2024
- Managed daily clinic operations to ensure effective patient care delivery.
- Coordinated scheduling for staff and patient appointments to optimize workflow.
- Oversaw compliance with healthcare regulations and quality standards.
- Assisted in training new staff on clinic procedures and protocols.
- Implemented process improvements to enhance operational efficiency in the clinic.
- Developed reports on clinic performance for management review meetings.
- Facilitated communication between clinical teams and administrative staff for seamless operations.
- Participated in meetings with other healthcare professionals to discuss best practices.
- Encouraged high morale and staff retention through effective communication, prompt problem resolution, proactive supervisory practices and facilitation of proactive work environment.
- Coordinated weekly work schedules for department employees.
- Developed and maintained clinical policies and procedures.
- Interacted with patients, asked appropriate questions and listened carefully to deliver high level of clinical care.
- Assisted with recruitment, selection, orientation and training activities for new employees.
- Delegated tasks to each member of staff and oversaw task completion, offering assistance to promote success.
- Enforced compliance with local, state and federal healthcare regulations, including Medicare and Medicaid requirements, HIPAA, OSHA and CLIA.
- Supervised staff in the delivery of patient care services.
- Interviewed applicants and made recommendations for new hires.
- Attended conferences and workshops to stay abreast of changes in the field.
- Created and implemented quality assurance programs to ensure patient safety and satisfaction.
- Monitored and tracked medication of patients and maintained medical equipment.
- Maintained cleanliness of medical, storage and common area rooms.
- Conducted regular reviews to evaluate effectiveness of care plans.
- Accurately created patient charts for new and existing patients, and implemented organizing systems to streamline patient records management.
- Investigated incidents or complaints related to clinical practice.
- Devised training programs to close gaps in nurse and staffs' competencies.
- Coordinated interdisciplinary teams for complex cases.
- Oversaw daily activities and interactions with patients.
- Ensured that staff members adhere to professional standards of practice.
Education
Associate of Applied Science - Surgical Technology
High Tech University
Orlando, FL05-1999
Skills
- Regulatory submission
- Quality assurance
- Project coordination
- Attention to detail
- Effective communication
- Time management
- Document management
Timeline
Regulatory Affairs Associate
Research
06.2025 - Current
Data Entry Clerk
Research
01.2025 - Current
Clinical Manager
Research
01.2023 - 05.2024
Assistant Clinical Research Coordinator
Research
05.2010 - Current
Laboratory Supervisor
Research
05.2010 - Current
Associate of Applied Science - Surgical Technology
High Tech University