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Senior Regulatory Affairs Specialist Resume Example

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SENIOR REGULATORY AFFAIRS SPECIALIST
Professional Summary
Accomplished Business Analyst GxP Systems versed in business systems analysis. Defines, analyzes and resolves complex enterprise-wide problems. Solution-oriented and driven with superior project management and leadership abilities.
Skills
  • Project Management
  • Product Safety management
  • Risk Based Validation
  • Business Process Mapping
  • SQL and databases
  • System Testing
  • Veeva/MasterControl
  • Statistical Reporting Tools
  • GxP Systems
  • Operations management
  • Technical Writing
  • Data Integrity
  • Streamline, Statistics
  • Backup, Technical Writing
  • Business processes, Training materials
  • Business Process, Training programs
  • Charts, Validation
  • Concise, Workflow
  • Clients
  • Databases
  • Decision-making
  • Team-building
  • Marketing
  • Meetings
  • Operations management
  • Personnel
  • Problem analysis
  • Process Development
  • Processes
  • Profit
  • Project Management
  • Quality
  • Quality Assurance
  • Quality control
  • Quality management
  • Recruiting
  • Reporting
  • Research
  • Safety
  • SQL
Work History
Senior Regulatory Affairs Specialist, 01/2019 to 12/2019
ACON Laboratories Inc – San Diego, CA
  • Promoted collaborative and coordinated change control planning with R&D, Marketing, Process Development and Quality Assurance teams.
  • Implemented regulatory guidance procedures to all product lines for FDA and EU regulatory bodies.
  • Reviewed files, records and other documents to obtain business information and key data informing responses to development requests.
  • Conducted interviews with key business users to collect information on business processes and user requirements.
  • Drove operational improvements which resulted in savings and improved profit margins.
  • Resolved conflicts and negotiated mutually beneficial agreements between parties.
QA Analyst, 04/2019 to 10/2019
San Diego, CA
  • Recommended improvements to processes, leading to reduction of wait times in developing and delivering drug product to 12 clients.
  • Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
  • Drove operational improvements which resulted in savings and improved profit margins by recruiting clinical patients for testing medical devices.
  • Boosted information sharing by enhancing interfaces between computer systems.
Quality Assurance Analyst, 01/2016 to 01/2018
Vical Incorporated – San Diego, CA
  • Provided support in Regulatory Affairs, Quality Assurance, Research, Clinical, Manufacturing and Corporate Development for a biopharmaceutical company that manufactures plasmid DNA-based vaccines.
  • Backup support to CEO and Board of Directors.
  • Boosted information sharing by enhancing interfaces between computer systems.
  • Produced charts and diagrams to assist with problem analysis.
  • Trained business personnel in use of quality management system.
  • Collected, defined and analyzed business requirements.
Business Systems Analyst, 01/2015 to 01/2016
Inova Diagnostics – Scripps Ranch, CA
  • Successfully juggled multiple projects simultaneously to aid executive leaders.
  • Assisted executive leaders in decision-making procedures by creating daily reports to advise leaders on corrective actions and process improvements.
  • Assessed personnel performance and implemented incentives and team-building events to boost morale.
  • Validated manufacturing and Quality assurance programs to meet strict design standards and FDA quality benchmarks.
  • Crafted training materials and ran on-boarding sessions to train 5 incoming team members.
Business Systems Analyst, 01/2013 to 01/2014
Sendx Medical, Inc – Carlsbad, CA
  • Improved quality processes for increased efficiency and effectiveness.
  • Updated quality control standards, methods and procedures to meet compliance requirements.
  • Sorted product and provided expertise on non-conforming product requirements.
  • Consulted literature to investigate software malfunctions.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Participated in weekly meetings with IT department.
  • Kept inspection journals and daily summary logs as required.
Business Process Analyst, 01/2012 to 01/2013
Alere, Inc – San Diego, CA
  • Enhanced training programs to strengthen employee knowledge and promote new managers from within.
  • Revitalized manufacturing area operational structures and procedures to successfully control turnover and waste, enhance output and boost overall quality.
  • Enforced regulatory and company policy compliance to improve workplace and employee safety and readiness.
  • Created and implemented strategies for improving operational efficiency and accuracy.
  • Identified areas of system improvement by applying historical knowledge to ongoing inferential statistics.
  • Conducted interviews with key business users to collect information on business processes and user requirements.
Education
Master of Business Administration: Business Administration And Management, 01/2015
Point Loma Nazarene University - San Diego, CA
Bachelor of Science: Biological Sciences, 05/2010
Point Loma Nazarene University - San Diego, CA
Work History
Senior Regulatory Affairs Specialist, 01/2019 to 12/2019
ACON Laboratories Inc – San Diego, CA
  • Promoted collaborative and coordinated change control planning with R&D, Marketing, Process Development and Quality Assurance teams.
  • Implemented regulatory guidance procedures to all product lines for FDA and EU regulatory bodies.
  • Reviewed files, records and other documents to obtain business information and key data informing responses to development requests.
  • Conducted interviews with key business users to collect information on business processes and user requirements.
  • Drove operational improvements which resulted in savings and improved profit margins.
  • Resolved conflicts and negotiated mutually beneficial agreements between parties.
QA Analyst, 04/2019 to 10/2019
San Diego, CA
  • Recommended improvements to processes, leading to reduction of wait times in developing and delivering drug product to 12 clients.
  • Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
  • Drove operational improvements which resulted in savings and improved profit margins by recruiting clinical patients for testing medical devices.
  • Boosted information sharing by enhancing interfaces between computer systems.
Quality Assurance Analyst, 01/2016 to 01/2018
Vical Incorporated – San Diego, CA
  • Provided support in Regulatory Affairs, Quality Assurance, Research, Clinical, Manufacturing and Corporate Development for a biopharmaceutical company that manufactures plasmid DNA-based vaccines.
  • Backup support to CEO and Board of Directors.
  • Boosted information sharing by enhancing interfaces between computer systems.
  • Produced charts and diagrams to assist with problem analysis.
  • Trained business personnel in use of quality management system.
  • Collected, defined and analyzed business requirements.
Business Systems Analyst, 01/2015 to 01/2016
Inova Diagnostics – Scripps Ranch, CA
  • Successfully juggled multiple projects simultaneously to aid executive leaders.
  • Assisted executive leaders in decision-making procedures by creating daily reports to advise leaders on corrective actions and process improvements.
  • Assessed personnel performance and implemented incentives and team-building events to boost morale.
  • Validated manufacturing and Quality assurance programs to meet strict design standards and FDA quality benchmarks.
  • Crafted training materials and ran on-boarding sessions to train 5 incoming team members.
Business Systems Analyst, 01/2013 to 01/2014
Sendx Medical, Inc – Carlsbad, CA
  • Improved quality processes for increased efficiency and effectiveness.
  • Updated quality control standards, methods and procedures to meet compliance requirements.
  • Sorted product and provided expertise on non-conforming product requirements.
  • Consulted literature to investigate software malfunctions.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Participated in weekly meetings with IT department.
  • Kept inspection journals and daily summary logs as required.
Business Process Analyst, 01/2012 to 01/2013
Alere, Inc – San Diego, CA
  • Enhanced training programs to strengthen employee knowledge and promote new managers from within.
  • Revitalized manufacturing area operational structures and procedures to successfully control turnover and waste, enhance output and boost overall quality.
  • Enforced regulatory and company policy compliance to improve workplace and employee safety and readiness.
  • Created and implemented strategies for improving operational efficiency and accuracy.
  • Identified areas of system improvement by applying historical knowledge to ongoing inferential statistics.
  • Conducted interviews with key business users to collect information on business processes and user requirements.
Personal Information
BILL & MELINDA GATES SCHOLAR , A recipient of the full scholarship provided by Bill & Melinda Foundation.
Skills
  • Project Management
  • Product Safety management
  • Risk Based Validation
  • Business Process Mapping
  • SQL and databases
  • System Testing
  • Veeva/MasterControl
  • Statistical Reporting Tools
  • GxP Systems
  • Operations management
  • Technical Writing
  • Data Integrity,
  • Streamline, Backup, business processes, Business Process, charts, concise, clients, databases, decision-making, team-building, Marketing, meetings, Operations management, personnel, problem analysis, Process Development, processes, profit, Project Management, quality, Quality Assurance, quality control, quality management, recruiting, Reporting, Research, Safety, SQL, statistics, Technical Writing, training materials, training programs, Validation, workflow
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    Resume Overview

    Companies Worked For:

    • ACON Laboratories Inc
    • Vical Incorporated
    • Inova Diagnostics
    • Sendx Medical, Inc
    • Alere, Inc

    School Attended

    • Point Loma Nazarene University

    Job Titles Held:

    • Senior Regulatory Affairs Specialist
    • QA Analyst
    • Quality Assurance Analyst
    • Business Systems Analyst
    • Business Process Analyst

    Degrees

    • Master of Business Administration : Business Administration And Management , 01/2015
      Bachelor of Science : Biological Sciences , 05/2010

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