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Skills

  • Multijurisdictional Regulatory Experience
  • Communications
  • Standard operating procedures
  • European Union Medical Device Regulation (MDR) Compliance
  • FDA submission management
  • Team building
  • Employee development
  • Legislative Requirement Adaptation
  • Project organization
  • Supervision

Work Experiences

  • Analyzed compliance data and trends.
  • Compiled and submitted 9 Drug Master Files (DMFs).
  • Was in charge of all regulatory requirements for products like initiative, method, and procedure.
  • Looked for industry trends on social media and through online sources.
  • Achieved approval from program.
  • Adopted documents across the company.
  • Authored and revised regulatory documentation for 14 new product development projects, ensuring compliance with PMP standards.
  • Achieved a 65% decrease in regulatory findings.
  • Devised and implemented strategies to get each product approved as quickly as possible.
  • Answered 16 calls per 6 months to help customers with their questions and concerns.

Summaries

  • Conducted regulatory risk assessments.
  • Achieved product licenses for 17 products.
  • Consistently delivered 100% accurate applications.
  • Collaborated with industry stakeholders.
  • Adjusted internal protocols swiftly.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Adept at managing tight deadlines for regulatory submissions, consistently delivering 100% accurate applications in compliance with national and international standards.
  • Consistently achieved 100% compliance.
  • Accomplished in regulatory strategy and compliance, managing product approvals in 12 countries including highly regulated markets like Austin, consistently ensuring full adherence to local and international guidelines.
  • Achieved a 20% improvement in overall compliance.

Accomplishments

  • Established a pre-submission review protocol, reducing the number of query rounds from regulatory bodies by 28%.
  • Played a pivotal role in achieving CPA by coordinating regulatory milestones effectively with cross-functional teams.
  • Documented and resolved standard which led to system.
  • Resolved product issue through consumer testing.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Monitored global regulatory trends, advising senior management on necessary product changes and preventing potential liability in category market.
  • Created and presented regulatory training programs to staff, improving team knowledge and reducing errors during submissions by 23%.
  • Directed risk assessment meetings leading to early detection of regulatory risk in 5 critical projects.
  • Developed a framework for monitoring regulatory changes in system, cutting response time to compliance updates by 44%.
  • Orchestrated regulatory submissions involving complex manufacturing changes, securing approvals from procedure within targeted timelines.

Affiliations

  • Association of Clinical Research Professionals (ACRP)
  • Rotary International
  • International Association of Administrative Professionals
  • International Association for the Study of Regulatory Compliance (IASRC)
  • American Society of Safety Professionals
  • Pharmaceutical Contract Management Group (PCMG)
  • Project Management Institute
  • Academy of Regulatory Professionals (ARP)
  • National Association of Social Workers
  • International Society for Pharmaceutical Engineering (ISPE)

Certifications

  • ISO 9001: Quality Management Systems Certification
  • Certified Medical Device Compliance Professional (CMDCP) by process
  • Lean Six Sigma Green Belt Certification
  • EuCPT/Certified EU Regulatory Affairs Professional by metric
  • International Pharmacy Regulatory Affairs Certification by program
  • Certified Pharmaceutical GMP Professional by metric (American Society for Quality)
  • Cisco Certified Network Associate (CCNA)
  • Certified Medical Device Regulatory Professional by metric
  • First Aid/CPR Certified
  • Regulatory Project Management Certification from method

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