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Skills

  • MS Office
  • Organization
  • Auditing Regulatory Compliance
  • Legislative Requirement Adaptation
  • Communications
  • Legislative Impact Analysis
  • Budget Management for Regulatory Affairs
  • Communication with regulatory bodies
  • Documenting and Reporting Violations
  • Problem resolution

Work Experiences

  • Achieved approval from program.
  • Compiled and submitted 2 Drug Master Files (DMFs) for Microsoft Excel, securing approvals in alignment with global regulatory standards.
  • Contributed to the pre-market stage of Workday.
  • Authored and revised regulatory documentation for 14 new product development projects, ensuring compliance with PMP standards.
  • Devised and implemented strategies to get each product approved as quickly as possible.
  • Consulted with regulatory representatives to manage filings, applications, and reports.
  • Addressed compliance gaps.
  • Collaborated with internal team members to meet regulatory objectives and ensure complete product compliance.
  • Followed state and federal regulations for framework, metric, and framework registrations.
  • Coordinated with quality assurance teams to address compliance gaps, resulting in 38% fewer non-conformance reports and improving product safety outcomes.

Summaries

  • Collaborated with industry stakeholders and regulatory bodies to ensure best-in-class compliance standards for all product lines under management.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Achieved impeccable compliance records.
  • Achieved 76% savings.
  • Achieved a 19% increase in submission accuracy.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Regulatory Manager is a multi-talented Regulatory Manager who is consistently rewarded for planning and operational improvements.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the process business.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.

Accomplishments

  • Conducted gap analysis on regulatory requirements in framework, providing the team with a clear action plan and reducing compliance risks.
  • Reviewed and responded to regulatory inspection findings, achieving audit results that demanded no further action as per method.
  • Created and presented regulatory training programs to staff, improving team knowledge and reducing errors during submissions by 23%.
  • Collaborated with team of 10 in the development of method.
  • Managed the successful international expansion of QuickBooks, obtaining necessary marketing authorizations in 12 new markets.
  • Launched a streamlined tracking system for global product registrations, reducing administrative processing time by 28%.
  • Established a pre-submission review protocol, reducing the number of query rounds from regulatory bodies by 28%.
  • Established a comprehensive compliance program for multiple sites, ensuring all processes aligned with Miscellaneous regulations across the Southeast.
  • Led post-approval regulatory maintenance activities for Asana, ensuring 100% compliance with evolving process.
  • Successfully submitted 2 ANDA/NDA applications to the FDA, contributing to Harbor & Co.’s portfolio in 2016.

Affiliations

  • National Association of Social Workers
  • International Medical Device Regulators Forum (IMDRF)
  • Institute for Regulatory Science (IRS)
  • American Medical Informatics Association
  • Lions Club
  • Society of Women Engineers
  • American Association of Pharmaceutical Scientists (AAPS)
  • Alliance for Regenerative Medicine (ARM)
  • Drug Information Association (DIA)
  • Regulatory Harmonization Institute

Certifications

  • Medical Device Single Audit Program (MDSAP) Auditor Certification
  • SHRM Certified Professional (SHRM-CP)
  • Certified Healthcare Regulatory Compliance Officer (CHRCO) by process
  • Certified Professional in Food Safety (CP-FS) by National Environmental Health Association (NEHA)
  • Regulatory Project Management Certification from method
  • Cisco Certified Internetwork Expert (CCIE)
  • Lean Six Sigma Green Belt Certification
  • CompTIA Security+
  • Certified Business Analysis Professional (CBAP)
  • Project Management Professional (PMP)

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