Regulatory Affairs Associate (Entry Level)
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Hiring Manager for Regulatory Affairs Associate (Entry Level) Roles
Compiled by: Kimberley Tyler-Smith
Senior Hiring Manager
20+ Years of Experience

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Regulatory Affairs Associate (Entry Level) Resume Sample

Your Name
Regulatory Affairs Associate (Entry Level)
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE June 2021 - May 2022
Regulatory Intern
Managed the preparation, submission, and maintenance of regulatory documents, increasing process efficiency by 30%
Strengthened compliance with 21 CFR Part 820/Part 11, reducing non-conformance issues by 40%
Implemented regulatory strategies for 10+ new products resulting in successful FDA clearances
Resume Worded September 2019 - May 2021
Research Assistant
Conducted comprehensive research on 50+ regulatory policies, trends, and procedures to support regulatory affairs team
Analyzed data from 5+ clinical trials, effectively informing product development planning
Collaborated in development of risk/benefit analysis for 20+ new products, informing regulatory decision making
Johnson & Johnson May 2018 - August 2019
Clinical Research Intern
Gathered and analyzed data from 3 major experimental studies, contributing to 15% improvement in methodology
Supported the development of study protocols for 3 clinical trials ensuring regulatory compliance
Resume Worded University May 2018
Master of Science in Regulatory Science
Elected Member of the Regulatory Affairs Professionals Society
Top 5% of class
Resume Worded Institute May 2016
Bachelor of Science in Biochemistry
Honors: Dean’s List (Top 10%)
Involved in various research and clinical projects
Regulatory Knowledge: FDA Guidelines, EU Guidelines, Regulatory Submissions, Good Clinical Practice (GCP), ICH Guidelines, Clinical Trials
Technical Skills: SPSS, MATLAB, MS Office (Excel, Word, PowerPoint), R, Python, Data Validation
Process Management: Regulation Compliance, Quality Assurance, Risk Management, SOP Development, Document Review, Report Writing
Certifications: Certified Regulatory Affairs Specialist (RAC), Good Clinical Practice (GCP) Certificate
Awards & Achievements: Awarded Regulatory Affairs Intern of the Year -, Johnson & Johnson Outstanding Intern Award
Volunteering: Volunteer Health and Safety Officer - Local Community Health Center
Professional Associations: Active Member of the Regulatory Affairs Professionals Society (RAPS)
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Compliance Analyst Resume Sample

Your Name
Compliance Analyst
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE January 2020 - Present
Compliance Intern
Developed and executed annual compliance training programs for 100+ employees, improving compliance understanding by 50%
Streamlined compliance reporting system and reduced process time by 35%
Monitored and analyzed 10+ regulatory environments to predict impacts on corporate operations
Resume Worded August 2018 - December 2019
Research Assistant
Performed in-depth research on regulatory compliance, directly supporting 5 company-wide projects
Coordinated with inter-department teams to ensure 100% compliance with local regulations
Created and maintained regulatory documentation database for efficient access and reference
Resume Worded University May 2020
Master of Business Administration - Compliance Management
Focus on Compliance Management and Finance
Recipient of the Academic Excellence Award in Business Studies
Resume Worded University June 2018
Bachelor of Law - Corporate Law
Specialization in Corporate Law
Dean's list for two consecutive years
Compliance: Regulatory Compliance, Compliance Analysis, AML, KYC, Anti-Bribery
Software: MS Office, SAP, Oracle ERP, Document Management Systems (DMS)
Research: Market Research, Quantitative Analysis, Qualitative Analysis, Data Interpretation, Reporting
Certifications: Certificate Program in Regulatory Compliance (2019), Certified Compliance and Ethics Professional (CCEP) (2021)
Volunteer Work: Legal Aid Society – Counseled and represented low-income clients in civil legal proceedings (2019-Present)
Awards & Achievements: Winner, Annual Compliance Ideas Contest, (2020), 'Employee of the Month' at Resume Worded (2019)
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Clinical Trials Coordinator Resume Sample

Your Name
Clinical Trials Coordinator
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded January 2021 - Present
Clinical Intern
Oversaw the coordination of 10+ clinical trials, improving trial timeline efficiency by 20%.
Utilized Medidata Rave for accurate and efficient data recording, reducing discrepancies by 15%
Coordinated 5 patient recruitment activities for studies, shortening recruitment timeline by two weeks June 2019 - December 2020
Research Associate
Analyzed patient data from 500+ cases, contributing to 10% improvement in patient care methodology
Participated in all phases of clinical trials, ensuring strict adherence to protocols and regulatory compliance
Resume Worded University May 2019
Master's Degree in Clinical Research
Thesis: The Role of Biostatistics in Clinical Trials
Resume Worded Institute May 2016
Bachelor of Science in Nursing
Minors in Health Informatics
Awards: Resume Worded Scholar 2014 (Top 5% of Class), Dean's List 2015 (Top 10%)
Clinical Research: Clinical Trial Protocols, Patient Recruitment, Data Management, Medication Administration, Adhering to Regulatory Guidelines, Patient Counseling
Technical Skills: Microsoft Office (Word, Excel, PowerPoint), Electronic Medical Records (EMR), SPSS Statistical Software, EDC Systems
Related Skills: Biostatistics, Medical Terminology, HIPAA Compliance, Informed Consent Process
Certifications: Clinical Research Coordinator Certification (CCRC), Good Clinical Practice (GCP) Certification
Volunteering: American Red Cross (Emergency Response Volunteer)
Projects: Coordination and execution of a clinical trial for Alzheimer's Disease at
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Clinical Research Associate Resume Sample

Your Name
Clinical Research Associate
City, Country  •  (123) 456-789  •  [email protected]  •
Johnson & Johnson June 2020 - Present
Clinical Research Intern
Reviewed and validated data for 20+ clinical trials, ensuring accuracy and completeness
Collaborated with site investigators to ensure study protocol adherence, achieving 98% compliance rate
Supported data management efforts, reducing discrepancies by 20%
Conducted comprehensive literature reviews and contributed to development of study protocols
Resume Worded May 2018 - May 2020
Research Assistant
Documented and processed clinical data from 50+ patients, supporting research objectives
Contributed to research design, resulting in 15% more efficient patient recruitment strategies
Resume Worded Academic Center May 2020
Master of Science in Clinical Research
Concentration in Clinical Trial Management and Design
Recipient of the Johnson & Johnson Clinical Research Scholarship (Top 10%)
Resume Worded University May 2018
Bachelor of Science in Biostatistics
Cumulative GPA: 3.85/4.00
Member of the Resume Worded Institute of Mathematical Statistics
Clinical Research: Patient Recruitment, Protocol Development, Data Collection & Analysis, Regulatory Compliance, Clinical Trials Management, Biostatistics
Software and Tools: Microsoft Office, SPSS, SAS, R, Clinical Data Management System (CDMS), Oracle Clinical, Medidata Rave
Regulations and Standards: ICH Guidelines, Good Clinical Practice (GCP), FDA Regulations, Health Insurance Portability and Accountability Act (HIPAA)
Certifications: Certified Clinical Data Manager (CCDM), Advanced Certificate in Clinical Trial Conduct and Management
Memberships: Active member of the Clinical Research Association (CRA), Society of Clinical Data Management (SCDM)
Volunteering: Health advocate volunteer at Med Hope Clinic, Biostatistics tutor with Volunteer Science Tutoring
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Quality Assurance Specialist Resume Sample

Your Name
Quality Assurance Specialist
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded June 2021 - Present
Quality Assurance Intern
Performed 50+ quality audits, and prevented 20 potential deviations
Trained 20+ new hires on quality control procedures, improving team efficiency by 30%
Performed data analysis and produced reports, resulting in 15% increase in productivity and a 10% reduction in waste September 2019 - May 2021
Research Associate
Contributed to quality-related research, informing the development of 5 new procedures
Analyzed and documented research findings in reports for company-wide distribution
Assisted in conducting field studies, providing data for 10+ quality improvement projects
Resume Worded University May 2019
Master of Science - Quality Management
Thesis: 'Implementation of Six Sigma in Software Testing'
Resume Worded Academic Center January 2021
Certified Software Tester (CSTE)
Focus on manual testing methodologies and automated testing using Selenium
Testing Tools: Selenium, QTP, JMeter, LoadRunner
Programming & Markup Languages: Java, Python, SQL, XML, HTML
Test Management & Bug Tracking Tools: TestRail, Zephyr, Bugzilla, Jira
Operating Systems: Windows, Linux, MacOS
Certifications: Certified Six Sigma Green Belt – American Society for Quality (ASQ)
Projects: Developed a test automation framework using Selenium, which reduced the testing cycle time by 30%
Awards: Quality Assurance Star – Resume Worded (June 2021)
Professional Memberships: Member, American Society for Quality (ASQ)

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