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Skills

  • Handling product variations in regulatory filings
  • Product lifecycle management from regulatory perspective
  • Project management
  • Team management
  • Negotiation with health authorities
  • Business operations
  • Forms management
  • Project organization
  • Budgets
  • Data verification

Work Experiences

  • Transported Asana to several months customer locations.
  • Answered 9 calls per two years to help customers with their questions and concerns.
  • Achieved QuickBooks approval in 2024.
  • Achieved compliance with FDA reporting timelines.
  • Assisted in the preparation and submission of global regulatory applications for standard, reducing time-to-market by 22%.
  • Collaborated with the legal department.
  • Assisted in developing regulatory submission checklists.
  • Collaborated with R&D to ensure that scientific justification dossiers met all regulatory standards, leading to approval in standard.
  • Collaborated with clinical teams to ensure investigational product labeling met both FDA and HSA (Health Sciences Authority) standards, with zero audit findings.
  • Oversaw the delivery of method project by framework team, which resulted in method.

Summaries

  • Offering 11 years of Miscellaneous experience and looking for a new challenge.
  • Built strong relationships with Chicago-based regulatory agencies.
  • Adapted strategies based on health authority requirements.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Achieved 36% improvement in regulatory timeline adherence.
  • Avoided market delays.
  • Collaborated with clinical departments.
  • Experienced in preparing and submitting regulatory documents, including reviewing materials, technical data, and filing accuracy.
  • Achieved 12 early-phase submissions.
  • With exceptional data analysis, report writing, and recordkeeping skills, I am articulate and personable.

Accomplishments

  • Enhanced communication across regulatory and clinical teams, reducing product launch delays by 84% across the Northeast.
  • Orchestrated regulatory due diligence during mergers and acquisitions, ensuring all compliance frameworks were aligned between 6 entities.
  • Initiated and executed post-market surveillance strategies, ensuring compliance and reducing pharmacovigilance issues by 18%.
  • Audited regulatory documentation processes, recommending improvements that reduced FDA audit findings by 72%.
  • Researched and compiled regulatory intelligence reports that guided strategic filing decisions, reducing development time by procedure.
  • Partnered with R&D and quality assurance teams to resolve regulatory concerns early in the product development cycle, reducing time to approval by 15 months.
  • Liaised with legal and intellectual property teams to navigate 18 regulatory patents, ensuring seamless product lifecycle management.
  • Tracked and analyzed legislative changes, adapting regulatory strategies to ensure compliance for existing products in framework.
  • Reduced post-approval compliance issues by 76% through the creation of a comprehensive risk management monitoring process for licensed products.
  • Monitored evolving regulatory guidelines and adapted strategies for 13 active submissions, ensuring compliance without project delays.

Affiliations

  • Society of Women Engineers
  • Pharmaceutical and Regulatory Liaison Committee (PRLC)
  • National Association of Social Workers
  • American Society of Safety Professionals
  • Freemason
  • Biotechnology Innovation Organization (BIO)
  • Association of Clinical Research Professionals (ACRP)
  • Medical Device Innovation Consortium (MDIC)
  • ACRP Certified Professionals in Regulatory Affairs (CPRAs)
  • Drug Information Association (DIA)

Certifications

  • Certificate in International Regulatory Affairs
  • Good Clinical Practice (GCP) Certification
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Clinical Research Professional (CCRP)
  • Certified Clinical Data Manager (CCDM)
  • DIA Regulatory Writing Certificate
  • ICH GCP E6(R2) Certification
  • FDA Compliance and Enforcement Training Certificate
  • Certified Business Analysis Professional (CBAP)
  • First Aid/CPR Certified

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