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Skills

  • MS Office
  • Communications
  • Process improvement initiatives
  • Audit management
  • Regulatory compliance
  • EMA regulatory compliance
  • Attention to Detail in Regulatory Documentation
  • Process improvement
  • Resource allocation
  • Problem resolution

Work Experiences

  • Achieved 100% compliance during 2023 by drafting precise, compliant labeling for consumer products across 18 markets.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Automated reporting for over 15 products.
  • Was in charge of all regulatory requirements for products like system, standard, and framework.
  • Achieved a record 84% on-time submission rate.
  • Collaborated with initiative customers to determine their needs and deliver process service.
  • Achieved a 57% decrease in regulatory deficiencies.
  • Achieved 100% compliance in 2016.
  • Saved $3 by putting in place cost-cutting measures that addressed long-standing issues.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.

Summaries

  • Collaborative Regulatory Coordinator.
  • Coordinated international product submissions in over 12 countries.
  • Achieved compliance excellence.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Strengths in risk assessment and process improvement backed up by Miscellaneous training.
  • Consistently met submission deadlines for 9 international agencies.
  • Accomplished Regulatory Coordinator who reduced product time-to-market by 20% through expertly handling regulatory submissions and amendments.
  • Dedicated to reducing compliance errors, delivering accurate regulatory documentation, and maintaining a 61% error-free submission rate over three years.
  • Analyzed regulatory guidelines.
  • Achieved a significant reduction in potential penalties.

Accomplishments

  • Played a critical role in redesigning regulatory data management system, reducing submission errors by 28% and increasing efficiency.
  • Actively engaged with stakeholders to resolve issues that delayed regulatory filings, achieving 53% on-time submission rate.
  • Developed and presented detailed regulatory strategy for program, improving approval turnaround by 51% across multiple regions.
  • Guided sales through successful product registration with program, aligning with all local regulatory expectations and achieving certification.
  • Coordinated regulatory activities for initiative across 17 regions, achieving global harmonized submission and faster approval times.
  • Authored and maintained Standard Operating Procedures (SOPs) for the regulatory submission process, ensuring 56% compliance with international standards.
  • Oversaw correction and resubmission of denied application, securing approval within 14 months and avoiding project shutdown.
  • Resolved product issue through consumer testing.
  • Maintained up-to-date knowledge of global regulatory guidelines, integrating new regulations into internal processes, preventing 5 potential compliance issues.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Affiliations

  • International Organization for Standardization (ISO) Committee Member
  • Quality Assurance Professionals of Austin
  • International Food Regulatory Authorities (IFRA)
  • Compliance Certification Course Completion (2016)
  • Advisory Board Member for Cedar Works - Regulatory Strategy
  • Lions Club
  • National Association of Regulatory Utility Commissioners (NARUC)
  • Jaycees
  • Certification in Regulatory Affairs (Scrum Master - 2016)
  • Regulatory Affairs Professionals Society (RAPS)

Certifications

  • Certified Clinical Research Associate (CCRA)
  • Certified Clinical Research Coordinator (CCRC)
  • EMA Clinical Trial Application (CTA) Submission Training
  • SHRM Certified Professional (SHRM-CP)
  • CompTIA Network+
  • Certified Supplier Quality Professional (CSQP)
  • Apple Certified Associate (ACA)
  • Certified Business Analysis Professional (CBAP)
  • Regulatory Affairs Certification (RAC) - Drugs
  • Cisco Certified Network Associate (CCNA)

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