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Skills

  • Business operations
  • Handling product variations in regulatory filings
  • Project organization
  • Category equipment
  • Data verification
  • Expedited review strategies with regulatory agencies
  • Relationship development
  • Team management
  • Negotiation with health authorities
  • Cost reduction strategies for regulatory processes

Work Experiences

  • Answered 9 calls per two years to help customers with their questions and concerns.
  • Consumer inquiries were received, researched, and resolved by me.
  • Collaborated with procedure customers to determine their needs and deliver standard service.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Collaborated with clinical teams to ensure investigational product labeling met both FDA and HSA (Health Sciences Authority) standards, with zero audit findings.
  • Assisted in the preparation and submission of global regulatory applications for standard, reducing time-to-market by 22%.
  • Achieved compliance with FDA reporting timelines.
  • Saved $9 by putting in place cost-cutting measures that addressed long-standing issues.
  • Collaborated with R&D on scientific justification dossiers.
  • Achieved early-phase submission by 16 weeks.

Summaries

  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.
  • Achieved product registration success.
  • Achieved approvals across 14 regions in 2015.
  • Adept Regulatory Affairs expert.
  • Regulatory Affairs Coordinator is a multi-talented Regulatory Affairs Coordinator who is consistently rewarded for planning and operational improvements.
  • Achieved 12 early-phase submissions.
  • Registrations, audits, inspections, and other category industry regulatory proceedings are all things that an experienced administrative professional is familiar with.
  • Strengths in workflow optimization and client relations backed up by Miscellaneous training.
  • Collaborated with consultants.
  • Within Miscellaneous, senior Regulatory Affairs Coordinator and outstanding performer in budget management and cross-functional collaboration.

Accomplishments

  • Established a robust tracking system to monitor submission timelines, resulting in 21% improvement in adherence to submission deadlines.
  • Drafted and standardized submission templates for investigational products, improving dossier consistency and reducing review cycles by 37%.
  • Developed structured communication protocols with local regulatory bodies, resolving issues 38% faster during license applications.
  • Reviewed and edited scientific rationales supporting clinical data for 16 pharmaceutical products, facilitating first-cycle approvals.
  • Audited regulatory documentation processes, recommending improvements that reduced FDA audit findings by 72%.
  • Facilitated regulatory submissions for 8 products across the Southwest ensuring timely approvals, which reduced time-to-market by 67%.
  • Successfully negotiated accelerated approval timelines with metric, securing regulatory clearance for new devices in procedure.
  • Spearheaded the transition of manual regulatory processes to an automated platform, decreasing submission errors by 46%.
  • Reviewed and approved product dossier submissions that accelerated regulatory approvals, reducing delays by 28%.
  • Collaborated with internal and external stakeholders to compile scientific justifications that led to successful product registrations with category across the Northeast.

Affiliations

  • Medical Device Innovation Consortium (MDIC)
  • World Health Organization (WHO) Regulatory Affairs Forums
  • American College of Healthcare Executives (ACHE)
  • American Society for Quality (ASQ)
  • National Association of Social Workers
  • Jaycees
  • Association of Clinical Research Professionals (ACRP)
  • Society of Toxicology (SOT)
  • Association for Computing Machinery
  • Clinical and Reproductive Regulatory Enforcement (CARE) Network

Certifications

  • DIA Regulatory Writing Certificate
  • ServSafe
  • Certified Quality Auditor (CQA)
  • Certified Regulatory Compliance Manager (CRCM)
  • Certificate in International Regulatory Affairs
  • Good Clinical Practice (GCP) Certification
  • Medical Device Submissions Certificate (FDA, EU MDR)
  • ISO 13485 Lead Auditor Certification
  • Certificate in Regulatory Affairs and Quality Assurance (RAQA)
  • Regulatory Strategy and Planning Professional Certificate

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