Regulatory Affairs Specialist

Regulatory Affairs Specialist Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Affairs Specialist 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
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Requirements
  • Medical Devices
  • Quality System
  • Good Manufacturing Practice (GMP)
  •  Find out what your resume's missing
  • ISO 13485
  • Standard Operating Procedure (SOP)
  • Corrective and Preventive Action (CAPA)
  • Design Control
  • Biotechnology
  • Validation
  • Regulatory Documentation
  • Clinical Trials
  • CE marking
  • Regulatory Compliance
  • Electronic Common Technical Document (eCTD)
  • Global Regulatory Compliance
  • Good Clinical Practice (GCP)

  •   Show full list

Resume Skills: Regulatory Knowledge

  • FDA and international regulations
  • GMP (Good Manufacturing practices)
  • GDP (Good Documentation practices)
  • GCP (Good Clinical practices)
  • Medical Device Directive (MDD)
  • FDA
  • EU-MDR
  • ICH
  • ISO 13485
  • ISO 9001
  • FDA Guidelines
  • EU Guidelines
  • Pharmaceuticals Legislation
  • Medical Device Directives (MDD)
  • ICH Guidelines
  • EU and U.S. FDA Regulations
  • Medical Device Single Audit Program (MDSAP)
  • Quality Management Systems (ISO 13485)
  • Good Clinical Practices (GCP)
  • FDA Regulations
  • CE Marking
  • MDR and IVDR
  • EMA
  • ICH and GxP guidelines
  • ISO 13485 and IEC 62304
  •  Match your resume to these skills

Resume Skills: Software

  • Microsoft Office Suite
  • SAP
  • TrackWise
  • MasterControl
  • Regulatory Information Management Systems (RIMS)
  • Veeva Vault RIM
  • Documentum
  • Project Management Software (Asana, Trello)
  • Document Control Systems (MasterControl)
  • Regulatory One
  • ennov Regulatory
  • LORENZ DocuBridge
  • RegTrak
  • Parexel Infosario
  • Ennov
  •  Match your resume to these skills

Resume Skills: Technical

  • MS Office
  • SAP
  • Documentum
  • Adobe Acrobat
  • SharePoint
  • TrackWise
  • AutoCAD
  • Quality Assurance
  • Quality Control
  • Regulatory Strategy
  • MS Office Proficient
  • Agile and Waterfall methodologies
  • SQL
  • Regulatory Information Management Systems (RIMs)
  • Electronic Document Management Systems (EDMS)
  • Statistical Analysis Software (SAS)
  • SOP Development
  • Clinical Trials
  • Risk Assessment (ISO 14971)
  •  Match your resume to these skills

Resume Skills: Certifications

Resume Skills: Quality Assurance Tools

Resume Skills: Compiling Documents

Resume Skills: Quality Assurance

Resume Skills: Languages

Resume Skills: Regulatory Affairs

Resume Skills: Quality Control & Assurance

  • Quality Assurance Monitoring
  • Deviation Management
  • Corrective and Preventive Action (CAPA)
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedures (SOPs)
  •  Match your resume to these skills

Resume Skills: Research Methods

  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 Specialist 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 Specialist 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.

Select a free resume example
Your Name
Regulatory Compliance Officer
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE July 2018 - Present
Regulatory Compliance Officer
Devised regulatory compliance strategies improving the firm's adherence to FDA laws by 40%.
Led audits for 5+ biotechnology projects without any adverse findings.
Conducted routine pay audits as part of regulatory compliance, saving the company $85K in potential fines.
Trained 20+ associates in Regulatory Compliance procedures, improving department performance by 15%
Developed and managed lifesciences product approval protocols, accelerating the product launch timeline by 20%.
Pfizer Feb 2015 - June 2018
Compliance Specialist
Enforced regulatory compliance across all operations, reducing process deviations by 25%.
Expedited internal audits successfully, meeting a 100% on-time evaluation rate.
Led design control activities, validating the performance of 10+ medical devices.
Boston Scientific Jan 2012 - Jan 2015
Quality Assurance Associate
Assisted in maintaining ISO 13485 certification, demonstrating commitment to quality standards.
Managed inspection database to track and reduce non-conformance incidents by 20%.
Resume Worded Institute May 2018
Certified in Risk and Information System Control (CRISC)
Gained proficiency in identifying enterprise risk and implementing controls to mitigate them
Resume Worded University December 2014
Master of Business Administration - Compliance Regulation
Focused on Financial Compliance and Law
Thesis: 'Effective Compliance Strategies in Pharmaceutical and Biotech Industries'
Compliance: Risk Analysis, Regulatory Intelligence, Regulatory Documentation, Compliance Monitoring, Reporting, Compliance Audits
Tools: Microsoft Office (Advanced), JIRA (Intermediate), Pfizer Compliance Management System (Proficient), ComplianceWire (Proficient)
Regulations: GDPR, SOX, HIPAA, Data Privacy Laws, FDA Regulations, Quality Assurance Guidelines
Certifications: Certified in Healthcare Compliance (CHC)
Publications: Wrote a well-received article in 'Compliance Today' magazine about 'The Importance of Compliance in Healthcare'
Conferences: Regular Attendee, International Compliance Professionals Association (ICPA) Annual Conference
Languages: English (Native), German (Professional Proficiency)
Your Name
Regulatory Affairs Associate
City, Country  •  (123) 456-789  •  [email protected]  •
Medtronic February 2021 - Present
Regulatory Affairs Associate
Prepared and submitted efficient eCTD applications, leading a significant decrease in approval time by 15%.
Efficiently interpreted and applied FDA regulatory requirements to company operations, reducing regulatory associated risks by 20%.
Partnered with cross-functional teams ensuring products meet applicable regulatory standards and requirements, alongside obtaining CE marking for three novel products.
Executed quality audits, propelling the implementation of pertinent corrective actions and regulatory compliance.
Resume Worded June 2018 - January 2021
Regulatory Affairs Coordinator
Maintained up-to-date knowledge of Global Regulatory Compliance contributing to the reduction of non-compliance instances by 30%.
Created easy-to-understand training materials on regulatory affairs and SOPs, increasing team awareness by 40%.
Participated in pre-submission and development stages of biotechnology products, reducing time to market by 20%. July 2016 - May 2018
Product Quality Analyst
Improved complaint handling efficiency by implementing enhanced techniques, reducing complaint backlog by 25%.
Assisted with monitoring of post-market product performances, thereby optimizing patient safety by 15%.
Resume Worded University June 2018
Master of Science - Regulatory Affairs for Drugs, Biologics, and Medical Devices
Recipient of Regulatory Affairs Academic Excellence Award
Resume Worded Academic Center May 2016
Bachelor of Science - Biomedical Engineering
Majored in Biomaterials & Medical Devices
Activities: Member, Biomedical Engineering Society (BMES)
Regulatory Knowledge: FDA and international regulations, GMP (Good Manufacturing practices), GDP (Good Documentation practices), GCP (Good Clinical practices), Medical Device Directive (MDD)
Technical Skills: MS Office, SAP, Documentum, Adobe Acrobat, SharePoint, TrackWise, AutoCAD
Certifications: Certified Quality Process Analyst (CQPA), Certified Regulatory Affairs Professional (CRAP)
Quality Assurance Tools: SPC (Statistical Process Control), Risk Management, CAPA (Corrective and Preventive Actions), Verification & Validation
Certifications: Certified Associate in Regulatory Affairs (CARA), Quality Management Systems (ISO 13485) certification
Leadership & Volunteering: Volunteer, Doctors Without Borders, Spearheaded a volunteer medical device donation program
Projects: Conducted a comparative study on Regulatory Concerns in Medical Devices between EU, US and Canada
Professional Development: Attended Annual Conference of Regulatory Affairs Professionals Society (RAPS) & Regulatory Convergence, 2019
Your Name
Regulatory Affairs Consultant
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE March 2021 - Present
Regulatory Affairs Consultant
Guided clients through complex regulatory landscapes facilitating the approval of five medical devices.
Worked with clients to ensure regulatory documentation is in line with industry standards, instrumental in reducing post-submission questions by 20%.
Provided expertise on regulatory affairs during Clinical Trials, enhancing trial success rates by 15%.
Assisted clients in achieving ISO 13485 compliance, enabling the broadening of their market reach.
Developed effective strategies to ensure adherence to Good Manufacturing Practice (GMP), improving manufacturing efficiencies by 25%.
Resume Worded July 2019 - February 2021
Regulatory Affairs Assistant
Conducted thorough market analysis regarding regulatory procedures, instrumental in the development of market entry strategies.
Supported in preparation of regulatory submissions in compliance with eCTD guidelines, accelerating approval times.
Implemented proper Design Control methodologies in product development cycles, improved product quality standards resulting in 15% fewer recalls.
Abbott labs June 2017 - June 2019
Junior Quality Analyst
Executed audit activities and compliance checks, identified gaps in processes and effective implementation of CAPA, reduced non-conformities by 10%.
Resume Worded University May 2017
Master of Science (MSc) in Regulatory Science
Top 5% of class, Graduated Cum Laude
Resume Worded Academic Center April 2019
Certified Regulatory Affairs Professional (CRAP)
Part-time Certification accomplished during Regulatory Affairs Assistant role at Resume Worded
Regulatory Software: RegTrak, Parexel Infosario, Ennov, Veeva Vault RIM
Regulatory Guidelines: FDA, EMA, ICH and GxP guidelines, MDR and IVDR, ISO 13485 and IEC 62304
Technical Skills: MS Office Proficient, Agile and Waterfall methodologies, SQL
Languages: English (Native), French (Conversational), German (Basic)
Certifications: Good Manufacturing Practice (GMP) Certification, Six Sigma Green Belt Certified
Leadership & Volunteering: Volunteer, United Way, Organized annual fundraisers raising over $20,000 annually
Awards: Recipient of Resume Worded Performance Excellence Award in 2020
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 Specialist resume?

Review the job posting closely.

Go through the Regulatory Affairs Specialist posting you're applying to, and identify hard skills the company is looking for. For example, skills like Regulatory Affairs, Regulatory Submissions and Medical Devices are possible skills. These are skills you should try to include on your resume.

Add industry skills like Good Manufacturing Practice (GMP) and Regulatory Requirements.

Add other common skills from your industry - such as Quality System, ISO 13485 and U.S. Food and Drug Administration (FDA) - into your resume if they're relevant.

Add skills into your work experience.

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

Show how you have strong attention to detail.

A good Regulatory Affairs Specialist has strong attention to detail, so try to include examples of where you handled complex projects or processes.

Use the exact job title.

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

Word Cloud for Regulatory Affairs Specialist Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Regulatory Affairs Specialist 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 Specialist Skills and Keywords to Include On Your Resume

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Regulatory Affairs Specialist 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

Resume Example
Regulatory Affairs Manager

Resume Example
Regulatory Affairs Associate (Entry Level)

Resume Example

Resume Example
Highlights (Free)

Resume Example
Modern Two-Column

Browse Skills from Similar Jobs

Frequently Asked Questions

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

Some popular Regulatory Affairs Specialist hard skills are Regulatory Affairs, Regulatory Submissions, U.S. Food and Drug Administration (FDA), Regulatory Requirements, Medical Devices, Quality System, Good Manufacturing Practice (GMP) and ISO 13485.

Depending on the job you apply to, skills like Design Control, Regulatory Compliance, Global Regulatory Compliance, CE marking and Standard Operating Procedure (SOP) can also be good 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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