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Skills

  • Improvement of operational capacity
  • Cross-functional team leadership
  • Regulatory compliance
  • Budgeting
  • Communications
  • Data collection and analysis
  • Risk mitigation strategies
  • Strategic planning
  • Supervision
  • Organization

Work Experiences

  • Aligned technical documentation for faster approvals.
  • Was in charge of maintaining store equipment such as computers, printers, and fax machines.
  • Identified process areas in need of improvement and implemented initiative program, resulting in a 13% increase in productivity.
  • Shared best practices with on-site and external personnel to align efforts and goals.
  • Presided over weekly meetings with executive leadership to identify areas for improvement, set milestones, and customize products for specific markets.
  • Oversaw quality programs aimed at reducing late compliance activities.
  • Updated processes on a regular basis to eliminate inconsistencies and improve scheduling across framework calendars and programs.
  • Welcomed new members and established and updated memberships in Lakeside Partners framework programs.
  • Acted as the primary point of contact with regulatory bodies, resolving critical filing issues and expediting the approval of SAP by 9 months.
  • Increased productivity by 17% while lowering staffing and operational costs.

Summaries

  • Offering a can-do attitude and a track record of success in coordinating and monitoring operations across multiple departments.
  • Dynamic application of client relations and project management in a fast-paced business environment.
  • To take on a new role in a standard setting, I'm ready to offer exceptional leadership and planning abilities.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Proactive Regulatory Project Manager uses determination and attention to detail to produce high-quality client relations work.
  • Regulatory Project Manager who is proactive and meticulous, with over 5 years of experience in the program industry.
  • Dedicated to providing high-quality services and products.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Regulatory Project Manager is a multi-talented Regulatory Project Manager who is consistently rewarded for planning and operational improvements.
  • Ability to use sound judgment and independent decision-making skills to positively impact company success.

Accomplishments

  • Played a pivotal role in the development and maintenance of regulatory documents by performing legal and technical file reviews, ensuring compliance with process standards.
  • Presented to senior management and board members on evolving regulatory landscapes, ensuring continuity by identifying critical compliance needs and onboarding 8 additional resources.
  • Collaborated with team of 16 in the development of initiative.
  • Achieved alignment between R&D and regulatory affairs teams, expediting the regulatory review process for a novel product by 19%.
  • Identified key differences in global market regulatory requirements for Power BI, adapting submissions accordingly and expediting approval by 6 months.
  • Restructured the regulatory filing process, leading to an 5 month reduction in the submission timeline for HubSpot.
  • Developed regulatory change control processes to efficiently address product modifications, minimizing regulatory review times by 30%.
  • Collaborated with the quality assurance team to ensure smooth submission of quality system documentation, reducing approval delays for procedure.
  • Reduced time-to-market for pharmaceutical products by collaborating with the manufacturing team during the submission of post-approval changes, minimizing review delays.
  • Directed multi-location regulatory projects, enabling the launch of QuickBooks in category with 100% regulatory compliance achieved within 9 months.

Affiliations

  • American Medical Informatics Association
  • Society of Human Resource Management
  • Good Clinical Practice (GCP) Compliance Certification
  • FDA Alumni Association
  • European Medicines Agency (EMA) Regulatory Science Network
  • Drug Information Association (DIA)
  • Parenteral Drug Association (PDA)
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Certified Clinical Project Manager (CPM)
  • Medical Device Manufacturers Association (MDMA)

Certifications

  • Certified Public Accountant (CPA)
  • Certified Change Management Professional (CCMP)
  • Certified Regulatory Compliance Manager (CRCM) – 2022
  • Certified in Risk and Information Systems Control (CRISC)
  • CompTIA Security+
  • ISO 9001:2015 Lead Auditor Certification
  • Certified Pharmaceutical Regulatory Compliance Professional (CPRCP)
  • Certified in Healthcare Compliance (CHC)
  • Project Management Professional (PMP) - Beacon Labs
  • Certified Professional in Healthcare Quality (CPHQ)

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