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Skills

  • Post-approval compliance monitoring
  • CAPA (Corrective and Preventive Actions) leadership
  • Multilingual proficiency in regulatory affairs
  • Data verification
  • Technical documentation
  • Expedited market clearance strategies
  • Process improvement
  • Multi-region regulatory compliance
  • Organization
  • Expertise in high-risk product approvals

Work Experiences

  • Authored regulatory submissions for standard biologics, successfully achieving market authorizations in 10 regions.
  • Answered 17 calls per 18 months to help customers with their questions and concerns.
  • Achieved market authorizations in 13 regions.
  • Advised on regulatory strategy for high-risk Adobe Creative Suite, resulting in the first-ever approval for standard indications in the Midwest.
  • Achieved faster submissions by 66%.
  • Accelerated product launch by 77%.
  • Achieved a 55% faster approval process.
  • Advised senior management on regulatory limitations.
  • Solved initiative issues, improved operations, and provided excellent customer service.
  • Conducted analyses across 13 regions.

Summaries

  • Achieved approvals in 18 regions.
  • Experienced in preparing and submitting regulatory documents, including reviewing materials, technical data, and filing accuracy.
  • Outstanding public relations abilities.
  • Accelerated product launches by 80%.
  • Costs were consistently reduced while profits were increased.
  • Detail-oriented Regulatory Affairs Consultant.
  • Accomplished Regulatory Affairs Consultant with successful experience preparing regulatory impact assessments for new industry standards, driving compliance initiatives by 2022.
  • Achieved significant revenue growth in global markets.
  • Dedicated consultant with strong interpersonal skills.
  • Registrations, audits, inspections, and other metric industry regulatory proceedings are all things that an experienced administrative professional is familiar with.

Accomplishments

  • Oversaw the regulatory aspects of product lifecycle from R&D to commercial launch, achieving FDA approval 13 months before projected date.
  • Developed and maintained a robust knowledge repository that centralized regulatory requirements, cutting down research time by 50% on future filings.
  • Analyzed new regulatory trends and communicated policy updates to upper management, enabling proactive compliance strategies and fostering innovation.
  • Led cross-functional working groups to ensure successful compliance with EU MDR regulations, facilitating continued product distribution in the EU.
  • Drove regulatory strategies for both pre-market and post-market activities, resulting in procedure product market authorization in the Southeast.
  • Collaborated with R&D teams to ensure all product modifications met regulatory standards, resulting in zero penalty findings during 2015 audits.
  • Successfully authored and reviewed Quality System Regulation (QSR) reports, achieving compliance with FDA requirements ahead of 2022 audit deadlines.
  • Authored regulatory filings for program biologic product, securing approvals in 9 global markets and boosting revenue potential by 23%.
  • Established cross-functional compliance programs that reduced incidents of non-compliance by 21%, aligning with corporate objectives.
  • Served as the regulatory lead on cross-border product registrations, ensuring adherence to unique regional requirements and expanding product reach by 20%.

Affiliations

  • Member, Biotechnology Industry Organization (BIO)
  • Association of Information Technology Professionals
  • Association for Computing Machinery
  • Regulatory Affairs Professionals Society (RAPS)
  • Society of Quality Assurance (SQA)
  • Member, Industry Advisory Committee on Standards (IACS)
  • Medical Device Innovation Consortium (MDIC) Member
  • Rotary International
  • Global Harmonization Task Force (GHTF) Membership
  • Advanced Certified Regulatory Affairs Specialist (RAC Advanced)

Certifications

  • Certified Clinical Research Professional (CCRP) by Society of Clinical Research Associates (SOCRA)
  • Certified in Healthcare Regulatory Compliance (CHRC)
  • Google Certified Professional Cloud Architect
  • Certified International Trade Professional (CITP) by Forum for International Trade Training
  • Certified Risk Management Professional (CRMP) by Meridian
  • ISO 13485 Quality Management Systems Certification by system
  • Certified Regulatory Compliance Manager (CRCM) by American Bankers Association (ABA)
  • Certified Clinical Research Coordinator (CCRC) by Association of Clinical Research Professionals (ACRP)
  • Certified in the International Council for Harmonisation (ICH) GCP Standards
  • Certificate in Emerging EU Medical Device Regulations

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