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Skills

  • Compliance Audit Failure Mitigation
  • Supervision
  • Technical documentation
  • Global Market Access Strategies
  • Adaptation to regulatory changes
  • Mentorship and coaching of junior staff
  • MS Office
  • Corrective action recommendations
  • Relationship development
  • Budgets

Work Experiences

  • Advised on strategic partnerships with compliance-friendly vendors.
  • Achieved approval 62% faster than industry benchmarks.
  • Coordinated regulatory intelligence activities.
  • Actions adopted by 43% of departments in 2023.
  • Addressed gaps in product labeling.
  • Contributed to regulatory submissions for high-priority products.
  • Avoided costly violations.
  • Analyzed cross-market regulations to guide global expansion, successfully securing product approvals in Chicago while cutting compliance costs by $17.
  • Built and maintained relationships with key regulatory agencies in Seattle, securing continuous support for navigating complex compliance landscapes.
  • Built relationships with key regulatory agencies.

Summaries

  • Senior Regulatory Review Specialist is a multi-talented Senior Regulatory Review Specialist who is consistently rewarded for planning and operational improvements.
  • Accomplished in regulatory strategy development.
  • Adept at auditing internal processes.
  • Avoided costly penalties.
  • Costs were consistently reduced while profits were increased.
  • Experienced in preparing and submitting regulatory documents, including reviewing materials, technical data, and filing accuracy.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Achieved 23% reduction in non-compliance cases.

Accomplishments

  • Monitored and analyzed regulatory changes in the Midwest, presenting timely recommendations to ensure complex market compliance.
  • Oversaw the complete re-certification process for 9 products, with a 17% success rate on the first submission.
  • Introduced a regulatory compliance alert system to track deadline-sensitive submissions, resulting in 85% increase in on-time filings.
  • Led cross-functional teams in regulatory strategy sessions, ensuring all products met Phoenix's regulatory requirements.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Resolved product issue through consumer testing.
  • Delivered comprehensive regulatory reports to senior management, helping to prioritize compliance initiatives by risk level and business impact.
  • Managed a regulatory budget exceeding $2, ensuring that compliance projects were completed under budget and regulatory deadlines were met.
  • Collaborated with regulatory bodies to accelerate product approvals, reducing time-to-market by 53%.
  • Documented and resolved framework which led to program.

Affiliations

  • Healthcare Compliance Association (HCCA)
  • Biotechnology Innovation Organization (BIO)
  • Society for Clinical Research Associates (SOCRA)
  • Association for Computing Machinery
  • Lions Club
  • Council on Regulatory Sciences (CRS)
  • Association for Supply Chain Management (APICS)
  • International Society for Therapeutic Innovation and Regulatory Science (DIA/TRS)
  • European Medicines Agency (EMA)
  • American Society for Quality (ASQ)

Certifications

  • Health Care Compliance Certificate Program by Seton Hall University
  • Certified in Regulatory Affairs for Pharmaceuticals and Medical Devices from Meridian
  • ISO 14971 Risk Management Certification for Medical Devices
  • Certified Clinical Research Professional (CCRP) by Society of Clinical Research Associates (SOCRA)
  • Certified Pharmacovigilance Professional (CPP)
  • FDA Regulatory Affairs Certificate
  • Certified Regulatory Compliance Manager (CRCM) by American Bankers Association
  • Certified Export Compliance Professional (ECoP)
  • Certified Public Accountant (CPA)
  • Certified Compliance & Ethics Professional (CCEP)

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