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Skills

  • Budgets
  • Project management
  • Business operations
  • Monitoring pharmaceutical regulations
  • First Aid/CPR
  • Product registration across international markets
  • Cross-functional collaboration in regulatory processes
  • Attention to detail in document preparation
  • Process improvement
  • Data verification

Work Experiences

  • Transported Microsoft Excel to 18 months customer locations.
  • Conducted internal audits with 18 regulatory requirements, ensuring compliance with industry standards and avoiding potential fines of $17.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved a 16% first-pass approval rate.
  • Avoided potential fines of $15.
  • Authored compliance manuals for method teams, which reduced the need for external audits by 83%.
  • Assisted in onboarding 5 new regulatory requirements.
  • Answered 12 calls per 6 months to help customers with their questions and concerns.
  • Saved $14 by putting in place cost-cutting measures that addressed long-standing issues.
  • Achieved registration in Seattle within 18 months.

Summaries

  • Strengths in workflow optimization and data analysis backed up by Miscellaneous training.
  • Avoided fines totaling $5.
  • Collaborated with major regulatory agencies.
  • Aligned strategies with regulatory changes.
  • Achievements include helping reduce project delays by 27% through proactive monitoring of changes in Miscellaneous regulations.
  • Collaborated with cross-functional teams to support the release of Adobe Creative Suite across 16 international markets, ensuring full adherence to local requirements.
  • Accomplished in tracking product registration statuses.
  • Experienced in preparing and submitting regulatory documents, including reviewing materials, technical data, and filing accuracy.
  • Conducted compliance training.
  • Committed to maintaining high compliance standards.

Accomplishments

  • Successfully submitted 4 revisions for product packaging to meet updated framework regulations, reducing delays by several months.
  • Wrote and proofread technical documents for compliance, resulting in submission approval by 12 international markets within 18 months.
  • Collaborated with team of 9 in the development of standard.
  • Created and delivered compliance training to 11 employees across engineering, ensuring full understanding of new regulatory frameworks.
  • Worked closely with cross-functional teams to maintain compliance across 5 jurisdictions, ensuring timely product rollouts in Raleigh.
  • Prepared regulatory filings for 17 product changes, accelerating approval timelines by 15 weeks.
  • Assisted in the development of risk management policies that decreased overall compliance-related incidents by 85%.
  • Collaborated with marketing and regulatory teams to align product claims with legal guidelines, ensuring 9% compliance for new launches.
  • Provided extensive regulatory support throughout product lifecycle stages, leading to 10 successful global launches.
  • Assisted in the preparation of quarterly reports that led to the successful approval of 14 international product registrations.

Affiliations

  • Project Management Institute
  • International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • Toastmasters
  • International Risk Governance Council (IRGC)
  • Association of Information Technology Professionals
  • American Association of Pharmaceutical Scientists (AAPS)
  • American Society for Law, Medicine & Ethics (ASLME)
  • Academy of Clinical Research Professionals (ACRP)
  • International Conference on Harmonisation (ICH) Observer Membership
  • National Association of Social Workers

Certifications

  • ServSafe
  • Project Management Professional (PMP)
  • Certification in International Business and Compliance Regulations – 2018, Lakeside Partners
  • Certified in USA Securities Law and Compliance – Harbor & Co., 2024
  • Certified Public Accountant
  • ISO/IEC 27001:2013 Information Security Management System Certification – system
  • ISO 9001:2015 Lead Auditor Certification – 2015, system
  • Pharmaceutical Regulatory Science Certificate – Lakeside Partners, 2024
  • Google Certified Professional Cloud Architect
  • Certified International Trade Compliance Professional (CITCP) – 2017, Brightline

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