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Skills

  • Program equipment
  • Business operations
  • CAPA (Corrective and Preventive Actions) leadership
  • FDA and EU MDR regulation training
  • Communications
  • Biologics market authorization preparation
  • Procedure statutes understanding
  • Regulatory compliance
  • Cross-functional team collaboration
  • Forms management

Work Experiences

  • Analyzed regulatory trends and provided early warning forecasts for potential impacts, contributing to Meridian’s proactive compliance strategy.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Authored regulatory submissions for standard biologics, successfully achieving market authorizations in 10 regions.
  • Coordinated with cross-functional teams to integrate new regulatory requirements for procedure software, ensuring FDA compliance and reducing timeline by 78%.
  • Conducted analyses across 13 regions.
  • Advised senior management on key regulatory limitations and opportunities, directly influencing company strategy for Asana expansion in the Southeast.
  • Achieved a 60% reduction in audit findings.
  • Boosted team efficiency.
  • Had an excellent attendance record and was always on time for work.
  • Solved initiative issues, improved operations, and provided excellent customer service.

Summaries

  • Outstanding public relations abilities.
  • Achieved approvals in 18 regions.
  • Offering 9 years of Miscellaneous experience and looking for a new challenge.
  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.
  • Achieved faster product approvals by 67%.
  • 16 years of experience in regulatory strategies.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the procedure business.
  • Within Miscellaneous, senior Regulatory Affairs Consultant and outstanding performer in strategic planning and stakeholder engagement.
  • Built strong relationships with regulatory bodies.

Accomplishments

  • Developed comprehensive training programs on regulatory compliance, reducing non-compliance incidents by 31% across 3 departments.
  • Partnered with clinical and legal teams to address and resolve FDA queries, ensuring smooth approval for QuickBooks without major delays.
  • Resolved product issue through consumer testing.
  • Led international regulatory submissions, securing product clearances in 11 countries and ensuring compliance with global standards.
  • Influenced the early-phase design of clinical trials, ensuring conformance with regulatory standards and reducing review cycles by 3 months.
  • Collaborated with R&D teams to ensure all product modifications met regulatory standards, resulting in zero penalty findings during 2015 audits.
  • Played a critical role in navigating complex regulatory pathways for novel therapies, securing breakthrough designation from the FDA in 2016.
  • Prepared and submitted clinical evaluation reports leading to successful licensing of standard in the Midwest, cutting time-to-market by 16 months.
  • Developed and maintained a robust knowledge repository that centralized regulatory requirements, cutting down research time by 50% on future filings.
  • Collaborated with team of 9 in the development of system.

Affiliations

  • International Trade Standardization Committee (ITSC) – Regulatory Focus
  • Lions Club
  • Jaycees
  • Association for Supply Chain Management (APICS)
  • American Marketing Association
  • Medical Device Manufacturers Association (MDMA)
  • European Medicines Agency (EMA) Advisory Panels
  • Panelist, International Pharmaceutical Regulators Programme (IPRP) 2022
  • American Society for Quality (ASQ) – Regulatory Affairs Focus Group
  • Compliance Lead, European Compliance Academy (ECA)

Certifications

  • Global Regulatory Affairs Certification by procedure
  • Regulatory Submissions and Electronic Common Technical Document (eCTD) Training
  • Certified Medical Device Regulatory Professional (CMDRP) by Regulatory Affairs Professional Society
  • Certified Public Accountant (CPA)
  • Advanced Regulatory Affairs Training by Drug Information Association (DIA)
  • Project Management Professional (PMP)
  • Certified in the International Council for Harmonisation (ICH) GCP Standards
  • CompTIA Network+
  • Certified Legal Compliance Professional (CLCP) by International Association of Risk and Compliance Professionals (IARCP)
  • Certified Regulatory Compliance Manager (CRCM) by American Bankers Association (ABA)

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