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Skills

  • Organization
  • Interpersonal and written communication
  • Product testing
  • Supervision
  • Team Leadership
  • Business operations
  • Document scanning
  • Data-driven decision making
  • First Aid/CPR
  • Risk management processes and analysis

Work Experiences

  • Adapted strategies in response to method.
  • Answered an average of 3 calls, emails, and faxes per day, responding to customer inquiries, resolving problems, and informing customers about new products.
  • Achieved regulatory clearance within 18 months.
  • Looked for industry trends on social media and through online sources.
  • Started two key partnerships that resulted in a 54% increase in revenue.
  • Copied, logged, and scanned supporting documents before filing everything in the client's files.
  • Achieved status in framework in 2015.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Created a new employee evaluation process that resulted in significant performance improvements.
  • Implemented marketing strategies that resulted in a 12% increase in the number of customers.

Summaries

  • Achieved faster market readiness.
  • Top-producing salesperson and industry expert in Miscellaneous.
  • Category are well-understood.
  • Costs were consistently reduced while profits were increased.
  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.
  • Accomplished Regulatory Specialist with expertise in FDA filings.
  • Adept at U.S. FDA and EU regulatory frameworks.
  • Achieved 8 successful product registrations.
  • 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.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.

Accomplishments

  • Initiated and led cross-functional working groups to prepare regulatory responses, driving a 83% reduction in FDA queries.
  • Developed and implemented regulatory strategies for international expansion, enabling market access in the Pacific Northwest and increasing revenue by $13.
  • Resolved product issue through consumer testing.
  • Worked closely with quality assurance to ensure that product labeling and packaging met compliance requirements for global distribution.
  • Supported clinical teams in preparing for FDA inspections by achieving clinical trial compliance with ICH-GCP standards for Power BI.
  • Developed a regulatory risk assessment tool that allowed for proactive planning and conflict mitigation in global product registration strategies.
  • Provided hands-on support for R&D by aligning product development with regulatory expectations, resulting in swift approval for key innovations.
  • Optimized the regulatory dossier preparation process, reducing review times by 5 days.
  • Key contributor to successful filing of 17 Investigational New Drug (IND) submissions in compliance with FDA standards.
  • Presented to the Board on major regulatory developments, outlining their potential impact on operations and advising on mitigation strategies.

Affiliations

  • U.S. Pharmacopeial Convention (USP) Committee
  • International Society for Medical Publication Professionals (ISMPP)
  • Association of Clinical Research Organizations (ACRO)
  • Certified International Regulatory Affairs (CIRA) Program
  • Health and Environmental Sciences Institute (HESI)
  • Project Management Institute
  • International Council of Nurses
  • Alliance for Regenerative Medicine (ARM) Member
  • Freemason
  • Lions Club

Certifications

  • Certified Therapeutic Goods Administration (TGA) Specialist
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Chartered Wealth Manager (CWM), certified by the American Academy of Financial Management (AAFM)
  • Google Certified Professional Cloud Architect
  • Good Automated Manufacturing Practice (GAMP) Certification
  • CLP (Certified Licensing Professional)
  • Association for Project Management (APM)
  • Auditing Clinical Trials for GCP Compliance Certification
  • Apple Certified Associate (ACA)
  • Salesforce

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