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Skills

  • Cross-functional collaboration
  • Team building
  • Regulatory Affairs Document Archiving
  • Forms management
  • FDA Submission Process Optimization
  • Category equipment
  • Communications
  • Effective written and verbal communication
  • Data Entry and Accuracy Review
  • Project management

Work Experiences

  • Collaborated with international teams.
  • Conducted regular audits of databases.
  • Answered 18 calls per one year to help customers with their questions and concerns.
  • Assisted with the review and submission of clinical trial protocols, ensuring timely approval in category, facilitating study start-up.
  • Archived clinical trial regulatory documents.
  • Assisted in the interpretation of regulatory guidelines and communicated complex information clearly to internal teams, improving compliance understanding.
  • Assisted in compiling detailed dossiers for QuickBooks regulatory submissions.
  • Assisted in interpreting regulatory guidelines.
  • Assisted with the review of clinical trial protocols.
  • Aided in 4 successful drug approvals.

Summaries

  • Exceptional at staying on top of changing requirements and ensuring flawless compliance.
  • Regulatory Affairs Intern with 16 years of successful client relations and team leadership experience.
  • Adept at drafting response letters for regulatory agency queries.
  • Addressed audit findings.
  • Conducted regulatory landscape assessments.
  • Committed to creating clear, timely, and well-informed responses to regulatory agency inquiries, always meeting deadlines and fostering positive relationships with regulatory bodies.
  • Collaborative Regulatory Affairs Intern.
  • Conducted regulatory intelligence gathering.
  • Committed to creating clear and timely responses.
  • Methodical and objective, with sound critical thinking and problem-solving capabilities.

Accomplishments

  • Resolved product issue through consumer testing.
  • Improved document tracking and submission accuracy through the introduction of Jira.
  • Coordinated with global regulatory teams to ensure uniformity in submissions and decrease the overall documentation review time by 65%.
  • Developed integrated go-to-market strategies for program to align with new regulatory policies from system.
  • Contributed to the launch of 5 medical devices through timely submission of accurate regulatory dossiers.
  • Reduced the cycle time for regulatory annual reports by 52% through process optimization.
  • Led efforts to standardize regulatory submission templates, reducing inconsistencies across 13 departments.
  • Collaborated with team of 2 in the development of program.
  • Supported the development of an internal regulatory audit preparation toolkit, reducing pre-audit preparation time by 11 days.
  • Authored regulatory evaluations of product risk-benefit profiles, supporting the strategic commercialization decisions for 2023.

Affiliations

  • Toastmasters
  • Society of Women Engineers
  • Association of Information Technology Professionals
  • Association for Accessible Medicines (AAM)
  • Healthcare Compliance Association (HCCA)
  • Project Lead, Regulatory Submission Forum (2018, Atlanta)
  • National Association of Regulatory Utility Commissioners (NARUC)
  • Society of Human Resource Management
  • Academy of Managed Care Pharmacy (AMCP)
  • Certified in Healthcare Compliance (CHC) – HCCA

Certifications

  • ISO 13485: Medical Devices Quality Management Systems Auditor Certification
  • Cisco Certified Internetwork Expert (CCIE)
  • Fundamentals of Pharmaceutical and Biologics Regulatory Affairs by Beacon Labs
  • Certified FDA Regulatory Submission Specialist
  • Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Certification
  • Regulatory Affairs in Emerging Markets Certification by process
  • Certified Clinical Research Coordinator (CCRC) by Accreditation of Clinical Research (ACRP)
  • Cisco Certified Network Associate (CCNA)
  • FDA Regulatory Compliance Certification by process
  • Certified in Regulatory Affairs for Cosmetics and Personal Care Products from system

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