Regulatory Affairs Coordinator

Regulatory Affairs Coordinator Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Affairs Coordinator job postings. In other words, these are the most sought after skills by recruiters and hiring managers. Go to Sample Templates ↓ below to see how to include them on your resume.

Remember that every job is different. Instead of including all keywords on your resume, identify those that are most relevant to the job you're applying to. Use the free Targeted Resume tool to help with this.

Choose a category
  • Regulatory Affairs
  • Good Clinical Practice (GCP)
  • Regulatory Submissions
  • Clinical Trials
  • Institutional Review Board (IRB)
  • Clinical Research
  • Regulatory Compliance
  •  Find out what your resume's missing
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Documentation
  • Oncology
  • Regulatory Requirements
  • Clinical Trial Management System (CTMS)
  • Overseas Sourcing
  • Clinical Development
  • Clinical Data Management
  • Healthcare
  • Standard Operating Procedure (SOP)
  • Oncology Clinical Research
  • Informed Consent
  • Life Sciences

  •   Show full list

Resume Skills: Regulatory Knowledge

  • ICH Guidelines
  • EU and U.S. FDA Regulations
  • Medical Device Single Audit Program (MDSAP)
  • Quality Management Systems (ISO 13485)
  • Good Clinical Practices (GCP)
  •  Match your resume to these skills

Resume Skills: Technical

Resume Skills: Research Methods

Resume Skills: Languages

Resume Skills: Regulatory Compliance

  • Premarket applications (510K, PMA)
  • Postmarket surveillance
  • Risk management (ISO 14971)
  • EU Medical Device Regulations
  • ICH guidelines
  • Quality Audit
  •  Match your resume to these skills

Resume Skills: Software

Resume Skills: Clinical Research

Resume Skills: Software Proficiency

Resume Skills: Data Analysis

  Does your resume contain all the right skills? Paste in your resume in the AI Resume Scan ↓ section below and get an instant score.

Compare Your Resume To These Regulatory Affairs Coordinator Skills (ATS Scan)

Paste your resume below and our AI will identify which keywords are missing from your resume from the list above (and what you need to include). Including the right keywords will help you get past Applicant Tracking Systems (i.e. resume screeners) which may scan your resume for keywords to see if you're a match for the job.

Sample Regulatory Affairs Coordinator Resume Examples: How To Include These Skills

Add keywords directly into your resume's work experiences, education or Skills section, like we've shown in the examples below. Use the examples below as inspiration.

Choose a template
Your Name
Regulatory Affairs Coordinator
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded July 2018 - Present
Regulatory Affairs Senior Associate
Streamlined the regulatory submission process by implementing automated tools and resources, increasing team efficiency by 35%
Orchestrated successful clinical trials in coordination with Good Clinical Practice (GCP), improving trial success rate by 20%
Diligently managed regulatory compliance, resulting in a 15% reduction in compliance issues
Conducted regulatory reviews for Clinical Trial Management System (CTMS) ensuring accuracy and completion
Championed the formation of a cross-functional Regulatory Affairs team, improving collaborative efforts by 45% January 2015 - June 2018
Regulatory Affairs Associate
Contributed to the establishment of standard operating procedures (SOPs) for the department, reducing errors by 40%
Supported Institutional Review Board (IRB) through meticulous submission of regulatory documents, achieving a 99% approval rate
Negotiated with U.S. Food and Drug Administration for product approval, shortening wait times by 10%
Novartis May 2011 - December 2014
Clinical Research Associate
Implemented clinical development plans and streamlined trial data management, improving data integrity by 50%
Managed multi-site international clinical trials, ensuring adherence to regulatory requirements
Reduced health risks by advocating for informed consent in the Clinical Research setup, ensuring thorough participant understanding
Resume Worded Institute June 2018
Certified Regulatory Affairs Professional (CRAP)
Certification recognized by the Regulatory Affairs Professionals Society (RAPS)
Resume Worded University April 2011
Master's Degree in Pharmacology
Concentration: Regulatory Sciences and Health Product Quality
Graduated with Distinction
Regulatory Compliance: Premarket applications (510K, PMA), Postmarket surveillance, Risk management (ISO 14971), EU Medical Device Regulations, ICH guidelines, Quality Audit
Software: SAP, Veeva Vault, Microsoft Office Suite, Visio, Project
Certifications: ISO 13485:2016 - Medical devices - Quality management systems
Languages: English (Native), Spanish (Fluent), French (Basic)
Leadership & Volunteering: Volunteer, Health Product Regulatory Professionals, mentoring new professionals in the regulatory affairs sector
Publications: Co-authored 'The changing landscape of medical device regulations in EU' in Health Technology journal
Your Name
Regulatory Affairs Specialist
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE August 2018 - Present
Regulatory Affairs Specialist
Revitalized existing regulatory affairs procedures in line with FDA guidelines, ensuring 100% compliance
Played integral role in managing oncology clinical research projects through proactive overseas sourcing
Leveraged deep understanding of Good Clinical Practice (GCP) to assist in clinical trials, increasing their success rate by 25%
Championed the implementation of a cutting-edge Clinical Trial Management System (CTMS), amplifying operation efficiency by 30%
Ameliorated regulatory submission process by proactively identifying and fixing potential issues, improving review times by 37%
Resume Worded April 2014 - July 2018
Regulatory Affairs Associate
Structured and managed institutional review board (IRB) submissions, achieving 98% approval rating
Ensured adherence to healthcare regulatory requirements during clinical development
Boosted regulatory compliance within the department through adoption of SOPs, reducing compliance incidents by 50%
GSK June 2010 - March 2014
Clinical Trial Associate
Facilitated the smooth conduct of clinical trials in line with GCP, contributing to a 30% success increase
Supported the production of regulatory documentation, ensuring completeness and transparency
Assisted in the coordination of fruitful overseas sourcing operations, optimizing resource allocation
Resume Worded Institute June 2015
Advanced Certification in Regulatory Compliance
Completed certification while maintaining full-time employment at Resume Worded
Resume Worded University May 2010
Master of Science in Pharmacology
Specialization in clinical trial design and regulation
Regulatory Knowledge: ICH Guidelines, EU and U.S. FDA Regulations, Medical Device Single Audit Program (MDSAP), Quality Management Systems (ISO 13485), Good Clinical Practices (GCP)
Technical Skills: MS Office, Regulatory Information Management Systems (RIMs), Electronic Document Management Systems (EDMS), Statistical Analysis Software (SAS)
Research Methods: Epidemiology, Pharmacoeconomics, Biostatistics, Health Outcomes Research, Systematic Reviews and Meta-Analyses, Pharmacoepidemiology
Languages: English (Native), French (Professional Proficiency)
Certifications: Certified Regulatory Affairs Specialist (RAC), Food and Drug Law Certificate
Professional Development: Completed American Management Association online courses in project management and leadership (2018 - 2020)
Volunteering: Mentor at BioPharma Professionals Network (Provided guidance to junior members on career advancement in regulatory affairs)
Publications: Published several articles in peer-reviewed ‘Journal of Regulatory Affairs’ on regulatory pathway strategies for medical devices
Your Name
Clinical Research Coordinator
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded September 2019 - Present
Clinical Research Coordinator
Directed all aspects of clinical trials, including site selection, trial setup, and data management, improving efficiency by 45%
Adeptly navigated regulatory submissions process, minimizing discrepancies by 30%
Implemented sound Clinical Trial Management System (CTMS), ensuring complete regulatory compliance
Enhanced patient consent process, improving participant understanding and emphasising ethics in clinical research
Established rigorous SOPs for clinical research, reducing trial errors by 40% April 2015 - August 2019
Clinical Research Associate
Fostered relationships with U.S. Food and Drug Administration, improving response times by 15%
Proactively advocated for stringent regulatory requirements across all projects, ensuring high compliance rate
Boosted successful clinical trial conduct through consistent alignment with Good Clinical Practice (GCP) principles
Pfizer January 2012 - March 2015
Clinical Research Assistant
Contributed significantly to streamlining data management processes in clinical trials, reducing data loss by 30%
Assisted in overseas sourcing operations, optimizing resource allocation
Supported IRB submissions, maintaining a solid track record of regulatory approval
Resume Worded University August 2011
Master of Science in Clinical Research
Awarded Fully Comprehensive Scholarship based on academic merit
Resume Worded Academic Center May 2010
Certification in Good Clinical Practice (GCP)
Completed the course while working part-time at Pfizer
Clinical Research: Protocol Development, Safety Monitoring, GCP Standards, Clinical Trials Administration, Regulatory Compliance
Software Proficiency: Medidata Rave, Oracle Clinical, CTMS, SPSS, MS Office Suite
Data Analysis: Quantitative Data Analysis, Qualitative Data Analysis, Biostatistics
Languages: English (Native), Spanish (Fluent)
Certifications: Certified Clinical Research Coordinator (CCRC), NIH Protecting Human Research Participants
Leadership & Volunteering: Volunteer Clinical Researcher, City Hospital; Chairperson, Clinical Research Forum, Resume Worded
Awards: Employee of the Year (2017), Pfizer Excellence Award for Research (2014)

How do I add skills to a Regulatory Affairs Coordinator resume?

Review the job posting closely.

Go through the Regulatory Affairs Coordinator posting you're applying to, and identify hard skills the company is looking for. For example, skills like Clinical Research, Good Clinical Practice (GCP) and Clinical Trials are possible skills. These are skills you should try to include on your resume.

Add industry skills like Regulatory Compliance and Institutional Review Board (IRB).

Add other common skills from your industry - such as Regulatory Affairs, Regulatory Submissions and U.S. Food and Drug Administration (FDA) - into your resume if they're relevant.

Add skills into your work experience.

Incorporate skills - like Regulatory Documentation, Regulatory Requirements and Standard Operating Procedure (SOP) - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Show evidence of your organization skills.

Time management is all about your ability to manage your time so you can accomplish all your responsibilities effectively.Regulatory Affairs Coordinator roles typically involve a range of different tasks so it can be beneficial to highlight your time management skills to hiring managers in your bullet points.

Show your ability to multitask.

Since you're going to be interfacing with different teams and people, Regulatory Affairs Coordinator hiring managers expect you to be able to multitask, so it's a good idea to emphasize this skillset in your resume.

Use the exact job title.

Try to add the exact job title, Regulatory Affairs Coordinator, somewhere into your resume to get past resume screeners. See the infographic for how to do this.

Word Cloud for Regulatory Affairs Coordinator Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Regulatory Affairs Coordinator job descriptions. The bigger the word, the more frequently it shows up on employer's job postings. If you have experience with these keywords, include them on your resume.

Top Regulatory Affairs Coordinator Skills and Keywords to Include On Your Resume

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Regulatory Affairs Coordinator Resume Templates

Here are examples of proven resumes in related jobs and industries, approved by experienced hiring managers. Use them as inspiration when you're writing your own resume. You can even download and edit the resume template in Google Docs.

Resume Example
Regulatory Affairs Specialist

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Regulatory Affairs Associate (Entry Level)

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Purchasing Coordinator

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Communications Coordinator / PR Coordinator

Browse Skills from Similar Jobs

Frequently Asked Questions

What skills do hiring managers want to see on a Regulatory Affairs Coordinator resume?

On top Regulatory Affairs Coordinator resumes, skills like Regulatory Affairs, Good Clinical Practice (GCP), Regulatory Submissions, Clinical Trials, Institutional Review Board (IRB), Clinical Research, Regulatory Compliance and U.S. Food and Drug Administration (FDA) appear most often.

Depending on the exact role you're applying to, skills like Regulatory Requirements, Standard Operating Procedure (SOP), Informed Consent, Healthcare and Regulatory Documentation can also be effective keywords to include on your resume.

Target your Resume to a Job Description

While the keywords above are a good indication of what skills you need on your resume, you should try to find additional keywords that are specific to the job. To do this, use the free Targeted Resume tool. It analyzes the job you are applying to and finds the most important keywords you need on your resume.

It is personalized to your resume, and is the best way to ensure your resume will pass the automated resume filters.

Start targeting your resume

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