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Skills

  • Budgets
  • Business operations
  • Project organization
  • Documentation standardization
  • Data verification
  • Communications
  • Compliance training development
  • Method compliance
  • Framework statutes understanding
  • Process improvement

Work Experiences

  • Coordinated regulatory intelligence activities to stay ahead of changing laws, resulting in the successful updating of compliance documents for metric products.
  • Achieved a 82% increase in successful FDA approvals.
  • Created a regulatory compliance dashboard, enabling real-time tracking of submissions and reducing report turnaround time by 32% hours.
  • Coordinated cross-border regulatory compliance efforts, reducing approval delays by 19% in Atlanta markets.
  • Analyzed regulatory trends.
  • Oversaw the delivery of framework project by standard team, which resulted in procedure.
  • Assessed impact on product portfolio.
  • Built and maintained relationships with key regulatory agencies in Seattle, securing continuous support for navigating complex compliance landscapes.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Collaborated with process customers to determine their needs and deliver initiative service.

Summaries

  • Accomplished in regulatory strategy development, successfully reducing time-to-market for 16 product lines in compliance with global standards.
  • Dedicated Senior Regulatory Review Specialist with a strong focus on compliance risk assessments, consistently driving down compliance audit failures by 35%.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Avoided costly penalties.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Specialized knowledge of how to manage complex documentation, reports, and data in the context of regulatory reporting and compliance.
  • Strengths in vendor management and project management backed up by Miscellaneous training.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Achieved approvals from 11 regulatory bodies.
  • Offering 12 years of Miscellaneous experience and looking for a new challenge.

Accomplishments

  • Developed a rigorous pre-approval submission review process that increased the first-pass regulatory approval rate by 59% %.
  • Led negotiations with regulatory authorities in the Southeast, ensuring favorably resolved compliance disputes that saved 2 in potential penalties.
  • Oversaw the complete re-certification process for 9 products, with a 17% success rate on the first submission.
  • Collaborated with regulatory bodies to accelerate product approvals, reducing time-to-market by 53%.
  • Delivered detailed training to regulatory teams on new documentation processes, leading to a decrease in non-compliance incidents by 84%
  • Documented and resolved framework which led to program.
  • Delivered comprehensive regulatory reports to senior management, helping to prioritize compliance initiatives by risk level and business impact.
  • Partnered with external consultants to ensure compliance with evolving regulatory requirements in the Southeast, reducing compliance failures by 43%.
  • Managed a regulatory budget exceeding $2, ensuring that compliance projects were completed under budget and regulatory deadlines were met.
  • Led the coordination and submission of supplemental regulatory filings post-market approval, improving product lifecycle management.

Affiliations

  • Association of Food and Drug Officials (AFDO)
  • Council on Regulatory Sciences (CRS)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Society of Toxicology (SOT)
  • Society of Human Resource Management
  • American Association of Pharmaceutical Scientists (AAPS)
  • Association for Supply Chain Management (APICS)
  • American Medical Informatics Association
  • American Society of Safety Professionals
  • Freemason

Certifications

  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Global Sanctions Specialist (CGSS)
  • Certified Export Compliance Professional (ECoP)
  • Certified Quality Auditor (CQA) from the American Society for Quality (ASQ)
  • Certified Global Regulatory Affairs Compliance Professional (GRACP)
  • Certified Information Privacy Professional (CIPP) from International Association of Privacy Professionals (IAPP)
  • Certified Clinical Research Professional (CCRP) by Society of Clinical Research Associates (SOCRA)
  • Project Management Professional (PMP)
  • CompTIA Network+
  • Pharmaceutical and Medical Device Compliance Certificate (Seton Hall University)

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