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Skills

  • Regulatory compliance
  • Global regulatory submissions
  • Project organization
  • Communications
  • Document control and quality systems management
  • Process improvement
  • Timeline management
  • Change Management
  • Customer service
  • Team management

Work Experiences

  • Achieved approval for Asana.
  • Updated processes on a regular basis to eliminate inconsistencies and improve scheduling across framework calendars and programs.
  • Established, enforced, and optimized internal policies to maintain efficiency and responsiveness to demands.
  • Improved filing systems for confidential client records and reports increased operational efficiency.
  • Reviewed established policies and procedures in order to assume temporary leadership roles, motivate employees, and ensure that metric operations ran smoothly.
  • Achieved first-in-class product recognition in Denver.
  • Acted as the primary point of contact with regulatory bodies, resolving critical filing issues and expediting the approval of SAP by 9 months.
  • Taught Regulatory Project Managers and Regulatory Project Managers effective customer service techniques, resulting in a 14% increase in client satisfaction.
  • Assessed suppliers in order to assess delivery quality, timeliness, and compliance, maintain tight cost controls, and maximize business operational efficiency.
  • Assessed employee performance over a two years period and provided constructive feedback to help them improve.

Summaries

  • Customer-focused professional with 3 years of experience in the Miscellaneous sector.
  • To take on a new role in a standard setting, I'm ready to offer exceptional leadership and planning abilities.
  • Dedicated to improving employee engagement and performance through training, monitoring, and morale-building.
  • Leader with an organized nature and an analytical problem-solving approach who is goal-oriented and enterprising.
  • Strengths in forming and maintaining relationships with a wide range of stakeholders in fast-paced, dynamic environments.
  • With forward-thinking leadership, proven skills in increasing productivity, efficiency, and bottom-line profits.
  • Collaborative, with a commitment to collaborating with coworkers to foster an engaged, empowering work environment.
  • Multi-tasking manager with a reputation for fostering a positive work environment and high-performing teams.
  • Results-oriented, goal-oriented, and looking to apply my experience to the role of Regulatory Project Manager.
  • Forward-thinking manager with 9 years of manufacturing project management experience.

Accomplishments

  • Restructured the regulatory filing process, leading to an 5 month reduction in the submission timeline for HubSpot.
  • Played a pivotal role in the development and maintenance of regulatory documents by performing legal and technical file reviews, ensuring compliance with process standards.
  • Directed multi-location regulatory projects, enabling the launch of QuickBooks in category with 100% regulatory compliance achieved within 9 months.
  • Created and implemented project risk assessment frameworks that reduced repetition in the submission process and facilitated faster responses to regulatory bodies.
  • Drafted meticulous protocols resulting in successful clinical trial data submissions for method, expediting long-term approvals for ServiceNow.
  • Achieved alignment between R&D and regulatory affairs teams, expediting the regulatory review process for a novel product by 19%.
  • Collaborated with the quality assurance team to ensure smooth submission of quality system documentation, reducing approval delays for procedure.
  • Collaborated with team of 16 in the development of initiative.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Reduced time-to-market for pharmaceutical products by collaborating with the manufacturing team during the submission of post-approval changes, minimizing review delays.

Affiliations

  • International Council for Harmonisation (ICH) Standards
  • International Organization for Standardization (ISO) Compliance Group
  • Society of Human Resource Management
  • American Association of Pharmaceutical Scientists (AAPS)
  • Jaycees
  • Association of Regulatory Professionals in Oncology (ARPO)
  • Certified Regulatory Compliance Manager (CRCM)
  • Society for Healthcare Regulatory Marketing (SHRM)
  • Certification in Regulatory and Quality Compliance (RQC)
  • Society of Clinical Research Associates (SOCRA)

Certifications

  • Certified in Risk and Information Systems Control (CRISC)
  • Google Certified Professional Cloud Architect
  • Apple Certified Associate (ACA)
  • First Aid/CPR Certified
  • Certified Clinical Project Manager (CCPM)
  • Professional Risk Manager (PRM) - 2022
  • Post Approval Changes Management Certification - the West Coast
  • ISO 9001:2015 Lead Auditor Certification
  • Fundamentals of Regulatory Auditing - framework
  • Certified in Market Authorization (MA) for Pharmaceuticals - the Pacific Northwest

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