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Skills

  • Technical documentation
  • System compliance
  • FDA Submission Process Optimization
  • Organization
  • Business operations
  • Cross-functional collaboration
  • Drug Label and Promotional Material Review
  • Database Management Systems Asana
  • Customer service
  • Project management

Work Experiences

  • Had an excellent attendance record and was always on time for work.
  • Assisted with the compilation of FDA Pre-IND meeting briefing books.
  • Accelerated approval timelines for Jira by 22%.
  • Checklist was adopted by the department.
  • Addressed regulatory audit findings.
  • Assisted in compiling detailed dossiers for QuickBooks regulatory submissions.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Collected and analyzed regulatory data for post-market surveillance reports, contributing to ongoing regulatory compliance of Jira.
  • Collaborated with cross-functional teams in compliance to ensure streamlined communication and efficient submission processes.
  • Contributed to discussions on risk management strategies.

Summaries

  • Accomplished risk identification and gap analysis in regulatory dossiers, improving compliance with regulations and reducing the risk of regulatory setbacks.
  • Addressed audit findings.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Aided in 7 FDA drug approvals.
  • Within Miscellaneous, senior Regulatory Affairs Intern and outstanding performer in process improvement and risk assessment.
  • Aided in thorough risk assessments.
  • Adept in regulatory affairs.
  • Regulatory Affairs Intern with 16 years of successful client relations and team leadership experience.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Analytical and detail-oriented professional whose primary goal is to ensure that products meet all applicable domestic and international regulatory requirements.

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Devised and implemented a regulatory document archiving system that improved file retrieval times by 38%.
  • Monitored key opinion leader feedback in the regulatory field, contributing to 2023 strategic adjustments.
  • Researched upcoming policy changes in the Pacific Northwest, providing a clear, actionable strategy to remain compliant in expanding the company’s presence.
  • Authored regulatory evaluations of product risk-benefit profiles, supporting the strategic commercialization decisions for 2023.
  • Contributed to project management in transitioning Tableau through the regulatory approval process in Denver, facilitating an standard approval.
  • Improved document tracking and submission accuracy through the introduction of Jira.
  • Provided insights on regulatory risks across different markets by compiling data from 4 international regulatory agencies.
  • Provided critical regulatory support in the preparation of Investigational New Drug (IND) applications, ensuring adherence to FDA guidelines.
  • Reviewed clinical trial documentation for regulatory accuracy, ensuring compliance in alignment with 2019 FDA guidelines.

Affiliations

  • Drug Information Association (DIA)
  • Society of Human Resource Management
  • International Council of Nurses
  • Certified in Healthcare Compliance (CHC) – HCCA
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Society for Clinical Research and Regulatory Affairs (SCRA)
  • Healthcare Compliance Association (HCCA)
  • International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
  • Toastmasters
  • Society of Women Engineers

Certifications

  • CompTIA Security+
  • ServSafe
  • ICH-GCP (International Conference on Harmonization - Good Clinical Practice) Certification
  • Postgraduate Certificate in Drug Development and Regulatory Sciences by process
  • Medical Device Lifecycle Management Certification
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified FDA Regulatory Submission Specialist
  • Certificate in Good Manufacturing Practices (GMP) for Pharmaceuticals by category
  • Medical Device Regulatory Affairs Certificate from metric
  • Cisco Certified Network Associate (CCNA)

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