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)
  • GxP (GMP/GCP/GLP)
  • 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
San Francisco, USA  •  (123) 456-789  •  yourname@resumeworded.com  •  linkedin.com/in/your-profile
EXPERIENCE
Coached.com  - Paris, FranceJuly 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  - Seattle, USAFeb 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  - San Antonio, USAJan 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%.
EDUCATION
Resume Worded Institute  - San Antonio, USAMay 2018
Certified in Risk and Information System Control (CRISC)
Gained proficiency in identifying enterprise risk and implementing controls to mitigate them
Resume Worded University  - Phoenix, USADecember 2014
Master of Business Administration - Compliance Regulation
Focused on Financial Compliance and Law
Thesis: 'Effective Compliance Strategies in Pharmaceutical and Biotech Industries'
SKILLS
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
OTHER
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)
Regulatory Compliance Officer

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

1
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.

2
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.

3
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.

4
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.

5
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
Professional


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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