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Skills

  • Extremely organized
  • Data entry
  • Hardware evaluation
  • Team building
  • Pricing tool development
  • Operational improvement
  • Data analysis
  • Food preparation
  • Process implementation
  • Process compliance

Work Experiences

  • Double-checked the data's accuracy and integrity.
  • Achieved no noted non-conformances.
  • Achieved a 45% reduction in corrective actions.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Had an excellent attendance record and was always on time for work.
  • Achieved zero financial penalties.
  • Examined departmental documents to determine how they should be distributed and filed.
  • Achieved regulatory clearance within 18 months.
  • Answered 7 calls per several months to help customers with their questions and concerns.
  • Achieved results in the first three years.

Summaries

  • Accomplished Regulatory Specialist with expertise in FDA filings.
  • Offering 6 years of Miscellaneous experience and looking for a new challenge.
  • Accomplished Regulatory Specialist with a history of securing initiative by managing global regulatory teams responsible for obtaining licenses in new markets. Implemented strategies that enhanced team productivity.
  • Knowledgable in a variety of design and testing methodologies.
  • Achieved 8 successful product registrations.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Team player who excels at collaborating with hardware and software experts to create a cohesive and successful design.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Clear understanding of project management and performance reporting as well as strategic planning training.
  • Achieved a 48% reduction in corrective actions.

Accomplishments

  • Collaborated with cross-functional teams to secure regulatory approval for QuickBooks, reducing time-to-market by 67%.
  • Led a root cause analysis team to address FDA 483 observations, resulting in corrective actions that passed re-inspection on the first attempt.
  • Resolved product issue through consumer testing.
  • Initiated and led cross-functional working groups to prepare regulatory responses, driving a 83% reduction in FDA queries.
  • Supported clinical teams in preparing for FDA inspections by achieving clinical trial compliance with ICH-GCP standards for Power BI.
  • Presented to the Board on major regulatory developments, outlining their potential impact on operations and advising on mitigation strategies.
  • Reviewed and harmonized company SOPs to align with current global regulatory best practices, resulting in 2 fewer compliance issues during audits.
  • Managed multiple regulatory projects simultaneously, achieving 3 on-time submissions within the deadlines for international product registrations.
  • Advised senior leadership on impending regulatory changes in the Southeast, mitigating compliance risks and avoiding potential penalties.
  • Worked closely with quality assurance to ensure that product labeling and packaging met compliance requirements for global distribution.

Affiliations

  • Parenteral Drug Association (PDA)
  • National Association for Biomedical Research (NABR)
  • Toastmasters
  • International Society for Medical Publication Professionals (ISMPP)
  • Center for Regulatory Excellence (CoRE)
  • Project Management Institute
  • Medical Device Innovation Consortium (MDIC)
  • Society for Risk Analysis (SRA)
  • Alliance for Regenerative Medicine (ARM) Member
  • Drug Information Association (DIA)

Certifications

  • Certified Regulatory Compliance Manager (CRCM)
  • Salesforce
  • Pharmaceutical Regulatory Affairs in the EU and USA Certification
  • Google Certified Professional Cloud Architect
  • FDA Regulatory Affairs Certificate Program
  • DIA Regulatory Affairs Certificate Program
  • Regulatory Compliance Specialist (RCS) Certification
  • ICH E6 R2 GCP for Clinical Trials Certification
  • ISO 9001 Lead Auditor Certification
  • Certified Pharmaceutical Industry Professional (CPhI)

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