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Skills

  • Customer service
  • Knowledge of ICH guidelines
  • Product lifecycle management
  • Legal and compliance partnership
  • Relationship development
  • Project organization
  • Regulatory compliance
  • Policy improvement initiatives
  • Knowledge of GxP practices
  • Resource allocation

Work Experiences

  • Devised and implemented strategies to get each product approved as quickly as possible.
  • Acted as liaison between company and program.
  • Advised management on compliance gaps.
  • Collaborated with R&D during product development stages, ensuring all products met regulatory requirements ahead of market release.
  • Achieved compliance ahead of market release.
  • Looked for industry trends on social media and through online sources.
  • Adapted to a constantly shifting landscape.
  • Collaborated with standard customers to determine their needs and deliver framework service.
  • Audited 10 product portfolios to confirm they met all relevant regulatory standards, discovering and resolving 17 significant issues.
  • Achieved an Employee of the Year for excellence in compliance.

Summaries

  • Within Miscellaneous, senior Regulatory Officer and outstanding performer in cross-functional collaboration and client relations.
  • Achieved successful approval of 17 critical products.
  • Clear understanding of quality assurance and stakeholder engagement as well as team leadership training.
  • Regulatory Officer is a multi-talented Regulatory Officer who is consistently rewarded for planning and operational improvements.
  • Accomplished Regulatory Officer.
  • Achieved first-time product approvals from procedure.
  • Advocate for speed and accuracy in regulatory processes.
  • Achieved expedited approvals for complex products.
  • Contributed to successful product launches.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.

Accomplishments

  • Created and led a regulatory governance framework, improving communication across 14 departments and ensuring proactive identification of compliance risks.
  • Reviewed scientific data to ensure compliance with regulatory standards, submitting corrective actions where required with initiative.
  • Monitored the evolving regulatory landscape and advised product development teams, enabling strategic adjustments that enhanced market positioning.
  • Collaborated with team of 9 in the development of initiative.
  • Facilitated cross-functional collaboration between regulatory, legal, and product teams, reducing time-to-market by 58% for new products.
  • Performed due diligence reviews for potential mergers and acquisitions, identifying regulatory liabilities and advising on mitigations.
  • Led a project to harmonize regulatory processes globally, standardizing documentation and reducing submission error rates by 43%.
  • Provided strategic direction on market withdrawals and product restorations, helping the company avoid $180,000 in potential regulatory sanctions.
  • Implemented digital tools for submission document tracking, reducing documentation errors by 48% and speeding up workflow approvals.
  • Developed a Compliance Action Plan adopted across the West Coast, reducing audit findings by 23%, thus ensuring all regulatory directives were met.

Affiliations

  • American National Standards Institute (ANSI)
  • Parenteral Drug Association (PDA)
  • International Conference on Harmonisation (ICH) Membership Program
  • Drug Information Association (DIA)
  • Health Product Regulatory Authority (HPRA) Professional Network
  • Compliance Professionals Association (CPA)
  • Institution of Engineering and Technology (IET)
  • Society of Women Engineers
  • Regulatory Science Network Netherlands (RSNN)
  • Society of Quality Assurance (SQA)

Certifications

  • Certified Quality Auditor (CQA) by American Society for Quality (ASQ)
  • Master Compliance Professional (MCP) Certification by procedure
  • Certified in Good Clinical Practice (GCP) by TransCelerate BioPharma
  • FDA Regulatory Affairs Regulatory Science Certification by system
  • Medical Device Risk Management Process Certification by initiative
  • Certified Director of Quality (CDQ) by International Academy of Business Professionals
  • Microsoft Certified Systems Engineer (MCSE)
  • Regulatory Project Management Certification by metric
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE) by American Society for Quality (ASQ)
  • Certified Professional in Healthcare Quality (CPHQ) – by National Association for Healthcare Quality (NAHQ)

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