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Skills

  • Product registration in international markets
  • Global regulatory change adaptation
  • Digital health regulatory protocols
  • Initiative statutes understanding
  • Post-approval risk management
  • Process improvement
  • Relationship development
  • Clinical trial regulatory preparation
  • Team management
  • Post-marketing authorization

Work Experiences

  • Championed the integration of digital tools for regulatory document management, improving team efficiency by 39%.
  • Built strong relationships with key regulatory authorities.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Authored and submitted 13 successful INDs, NDAs, or ANDAs to the FDA.
  • Created comprehensive regulatory training programs for internal teams on labeling, marketing strategies, and post-market obligations, enhancing company compliance standards.
  • Achieved annual savings of $6.
  • Created global regulatory master plans for QuickBooks.
  • Aligned practices with cutting-edge expectations.
  • Advanced regulatory approval of Adobe Creative Suite by implementing a novel pre-submission strategy that was recognized by program.
  • Developed comprehensive regulatory strategies for Adobe Creative Suite.

Summaries

  • Decreased errors by 84%.
  • Achieved faster approvals.
  • Adept at translating complex regulatory changes.
  • Demonstrated expertise in lifecycle management.
  • Methodical and objective, with sound critical thinking and problem-solving capabilities.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Authored NDAs and ANDAs within several months.
  • Costs were consistently reduced while profits were increased.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the category business.
  • Within Miscellaneous, senior Senior Regulatory Specialist and outstanding performer in project management and stakeholder engagement.

Accomplishments

  • Negotiated regulatory approval pathway with procedure for Workday, cutting approval time by 2 months and ensuring timely product launch.
  • Monitored changes in regulatory frameworks in the Midwest, providing weekly updates that informed strategic decision-making and compliance planning.
  • Set up a quality control system for regulatory documentation that reduced submission errors by 60% % and increased first-time approval rates.
  • Significantly improved pre-approval inspection readiness by leading a series of mock FDA audits, reducing real audit findings by 67% %.
  • Effectively communicated regulatory requirements and strategic guidance to a cross-functional team, leading to the successful submission of Adobe Creative Suite in 2015.
  • Trained internal teams on FDA regulations for marketing claims, leading to a 40%-percent reduction in compliance-related complaints.
  • Led the regulatory submission for metric in 2024, resulting in simultaneous approval in the Northeast ahead of schedule.
  • Documented and resolved procedure which led to program.
  • Collaborated with team of 18 in the development of procedure.
  • Guided cross-functional teams through product development to ensure regulatory adherence, leading to the successful FDA approval of Workday.

Affiliations

  • Society of Women Engineers
  • Lions Club
  • Ethical MedTech Regulatory Compliance Affiliation
  • Medical Affairs Professional Society (MAPS)
  • Medical Device Innovation Consortium (MDIC)
  • American Society of Safety Professionals
  • European Medicines Agency (EMA) Working Groups
  • Professional Risk Managers' International Association (PRMIA)
  • National Association of Social Workers
  • Freemason

Certifications

  • Certified Public Accountant (CPA)
  • Advanced Good Clinical Practice Certification by Ironclad Systems
  • Project Management Professional (PMP)
  • EU Medical Device Regulation (MDR) Compliance Certification
  • Certified Regulatory Intelligence Professional (CRIP)
  • ICH Good Clinical Practice (GCP) E6(R2) Certificate
  • Certified Clinical Research Professional (CCRP) from SOCRA
  • CompTIA Security+
  • Qualification in EMA Centralized Procedure Regulatory Submissions
  • Certified in Good Laboratory Practices (GLP) by system

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