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president executive director ceo resume example with 15+ years of experience

Jessica Claire
, , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Summary

Knowledgeable CEO and FDA Regulatory Affairs Officer with over 16+ years of experience bringing planning and problem-solving abilities. Focused on maximizing resource utilization to support scalable operations and increase bottom-line profitability. Organized and systematic with natural relationship-building and leadership talents.

Skills
  • Strategic planning
  • Audit oversight
  • Budget administration
  • SOP development
  • Agency inspection support
  • Planning & organizing
  • Technical guidance
  • Impact assessment
  • Data management
  • Controls systems enhancement
  • Market access and expansion
  • Market trend expertise
  • Mergers & acquisitions
  • Corporate leadership
  • Profit & Loss
  • Cash Flow analysis
  • Procedure redesign
  • Business alliances
  • Business development
  • Operating budgets
  • Market strategies
  • Shareholder accountability
  • Regulatory compliance
  • Productivity performance
  • Organizational leadership
  • Executive leadership
  • Financial administration
  • Relationship management
  • Risk management
Experience
09/2007 to Current
President /Executive Director /CEO Pharmica Consulting Palo Alto, CA,
  • Submitted FDA applications and amendments to regulatory agencies.
  • Provided strategic regulatory input to internal and external stakeholders in compliance with FDA regulations.
  • Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
  • Managed regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
  • Guided negotiations with Pharmaceutical regulatory authorities to gain approval for Phase I - IV clinical trials.
  • Provided strategic regulatory input to internal and external stakeholders in compliance with FDA regulations.
  • Provided regulatory guidance to departments or development project teams regarding design, development, evaluation or marketing of products.
  • Summarized field studies and laboratory reports to understand current data and make effective plans.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Gathered and analyzed scientific data to formulate explanations and arguments for regulatory authorities.
  • Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics.
  • Researched new regulatory requirements for FDA / FQHC to gather information and launch resulting organizational changes.
  • Conducted market research activities and competitive analysis to facilitate implementation of aggressive company marketing strategy.
  • Reviewed site and department performance to improve quality of services and comply with regulatory requirements.
  • Assessed and evaluated business procedures and implemented structure to improve day-to-day operations.
  • Monitored organization's internal practices to comply with government regulations.
  • Oversaw and coordinated development of annual reports.
  • Collaborated across internal departments to achieve regulatory objectives and maintain compliance of products.
  • Developed and implemented strategies to obtain timely approvals for each application.
  • Investigated product complaints and prepared documentation and submissions to appropriate regulatory agencies.
  • Submitted fees and applications, tracked status updates and handled all correspondence during regulatory affairs processes.
01/2022 to 11/2022
Executive Director /CEO SAHARA Foundation City, STATE,
  • Oversaw budgetary and financial activities and implemented strategies to grow business and profits.
  • Led organization by establishing business direction and actualizing operational plans to meet goals.
  • Planned and executed compliance audits to check company policies, procedures and controls.
  • Maintained and revised policy procedures for general operation of compliance program.
  • Analyzed data from multiple sources to systematically document work and results.
06/2021 to 10/2022
Regulatory Affairs Consultant Strata Healthcare City, STATE,
  • Monitored competitor activity, legislative and regulatory initiatives and agency concerns and contracts and developed strategies to respond.
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Organized and maintained all files related to regulatory actions.
  • Wrote comprehensive reports outlining findings and translating concepts for technical and non-technical audiences.
  • Performed quantitative and qualitative evaluations to measure effectiveness of field programs and operations.
  • Researched, analyzed and solved revenue management questions, including forecasting and inventory.
04/2015 to 11/2016
President of Operations and Human Resource Brookline Institute City, STATE,

  • Supervised HR Department employees by directing activities and monitoring performance.
  • Developed hiring and recruitment policies to drive transparent and fair hiring process for selecting candidates on basis of merit and relevance with job.
  • Devised and executed employee development, performance oversight, compensation and benefits programs.
  • Worked closely with CHRO to inform of upcoming commitments and responsibilities.
  • Created succession plans and promotion paths for staff to boost passion for reaching goals and objectives of organization.
  • Assessed financial reports and statements to review quarterly and annual performance.
  • Developed and deepened relationships with functional leadership to interconnect revenue generation initiatives with day-to-day operations.
  • Improved operational efficiencies by analyzing issues and implementing project management.
  • Analyzed expenses and revenues and compared to budget and forecasts to modify operations and spending for enhanced profitability.
Education and Training
Expected in 09/2023 to to
Master of Science: Health Care Administration
Brookline College - Phoenix - Phoenix, AZ
GPA:
Expected in 09/2007 to to
M.D.: Administration And Regulatory Affairs
CA Health Sciences University - Belize City, BZ,
GPA:
Expected in 05/2003 to to
Bachelor of Arts: Political Science
University of Pittsburgh - Pittsburgh, PA
GPA:

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Resume Overview

School Attended

  • Brookline College - Phoenix
  • CA Health Sciences University
  • University of Pittsburgh

Job Titles Held:

  • President /Executive Director /CEO
  • Executive Director /CEO
  • Regulatory Affairs Consultant
  • President of Operations and Human Resource

Degrees

  • Master of Science
  • M.D.
  • Bachelor of Arts

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