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Skills

  • Product launch support through regulatory channels
  • Certification acquisition for market expansion
  • Market access expansion through regulatory approval
  • Collaboration with regulatory authorities
  • Supervision
  • Multinational product submissions
  • Compliance with evolving standards
  • Advising on product development regulations
  • Product portfolio compliance management
  • Market-specific regulatory expertise

Work Experiences

  • Collaborated with the clinical team.
  • Achieved a 47% reduction in approval time.
  • Coordinated document exchange with regulatory health authorities.
  • Achieved Scrum Master in record time.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Created and implemented regulatory affairs SOPs, leading to improved operational efficiency and a 15% decrease in errors.
  • Consumer inquiries were received, researched, and resolved by me.
  • Collaborated with the clinical team to design regulatory strategies that supported early phase product development, accelerating product pipelines by 3 months.
  • Advised product development teams on regulatory requirements, resulting in HubSpot receiving regulatory approval in Atlanta under 3 weeks.
  • Created comprehensive gap analyses of global regulations, enabling the company to adapt its Adobe Creative Suite portfolio in compliance with program across the Pacific Northwest.

Summaries

  • Contributed to a 57% reduction in non-compliance cases.
  • Cross-functional collaboration expert.
  • Accelerated approval processes for Salesforce by 48%.
  • Consistently delivered on-time approvals.
  • Regulatory Affairs Assurance Associate with 18 years of successful risk assessment and budget management experience.
  • Accelerated the speed of approval by 55%.
  • Aligned regulatory, legal, and R&D teams.
  • Clear understanding of strategic planning and budget management as well as cross-functional collaboration training.
  • Authored and managed submissions across 15 countries.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.

Accomplishments

  • Optimized regulatory submission workflows using SAP, resulting in a 21% reduction in document preparation time.
  • Interpreted and applied regulatory guidelines from the Northeast, ensuring compliance across 2 product lines in method.
  • Regularly interfaced with the Pacific Northwest health authorities to ensure pre-approval inspections for QuickBooks were completed on schedule.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Conducted risk assessments for regulatory non-compliance in new markets, reducing potential penalties by 67% through proactive planning.
  • Coordinated with global regulatory bodies in the West Coast, ensuring compliance with shifting market-specific regulations for Power BI across 9 countries.
  • Developed and managed key performance indicators (KPIs) for regulatory submissions, improving team performance by 75% year-over-year.
  • Led regulatory compliance audits for Power BI, identifying and resolving 12 non-compliance issues in under 11 weeks.
  • Proactively managed post-market surveillance of Salesforce to ensure continuous compliance with evolving regulations in the Pacific Northwest.
  • Led the regulatory document harmonization process across 5 regions, ensuring consistency in product claims and requirements.

Affiliations

  • Certified Regulatory Affairs Specialist (RAC) Certification
  • Member of the Compliance and Ethics Leadership Council
  • American Association of Pharmaceuticals Scientists (AAPS)
  • Society for Clinical Data Management (SCDM)
  • Active participant in FDA Guidance Workshops
  • International Council of Nurses
  • Pharmaceutical Compliance Forum (PCF)
  • Good Regulatory Practice (GRP) Certification
  • International Association of Administrative Professionals
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)

Certifications

  • Regulatory Affairs Certification (RAC) - Summit Group
  • CompTIA Network+
  • Graduate Certificate in Regulatory Affairs – Northwind
  • Certified Public Accountant (CPA)
  • Certified Quality Auditor (CQA) Northwind
  • Certified Public Accountant
  • Certified Good Manufacturing Practices (GMP) Professional – 2021
  • Certified RA Submission Specialist (CRSS) – Tableau
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA A+ Technician

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