Regulatory Affairs Associate

Regulatory Affairs Associate Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Affairs Associate 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)
  • Electronic Common Technical Document (eCTD)
  • Standard Operating Procedure (SOP)
  • Regulatory Requirements
  • Good Manufacturing Practice (GMP)
  •  Find out what your resume's missing
  • Biotechnology
  • Regulatory Documentation
  • Pharmaceutics
  • Medical Devices
  • CMC Regulatory Affairs
  • IND
  • Life Sciences
  • Clinical Trials
  • New Drug Application (NDA)
  • Drug Development
  • Abbreviated New Drug Application (ANDA)
  • Quality System
  • Change Control

  •   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 Guidelines
  • EU Guidelines
  • Pharmaceuticals Legislation
  • ISO 13485
  • Medical Device Directives (MDD)
  • FDA regulations
  • EMA regulations
  • ICH guidelines
  • Health Canada regulations
  • Quality Management Systems (QMS) (ISO 13485)
  •  Match your resume to these skills

Resume Skills: Technical

Resume Skills: Certifications

Resume Skills: Quality Assurance Tools

Resume Skills: Software and Tools

Resume Skills: Quality Assurance

Resume Skills: Languages

Resume Skills: Regulatory Compliance

Resume Skills: Software Proficiency

Resume Skills: Process & Quality Assurance

Resume Skills: Industries

Resume Skills: Frameworks & Methodologies

  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 Associate 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 Associate 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 Associate
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE June 2019 - Present
Regulatory Affairs Associate
Initiated a SOP, reducing the document processing time by 70%
Successfully coordinated regulatory submissions, reducing lag time by 30%
Navigated complex Regulatory Requirements efficiently, leading to a 25% fast-tracking in product approvals
Developed an innovative Good Manufacturing Practice (GMP) workflow, increasing production efficiency by 18%
Spearheaded the creation of eCTD for critical projects with 100% success rate
Johnson & Johnson May 2015 - May 2019
Regulatory Affairs Specialist
Streamlined CMC Regulatory Affairs processes, improving efficiency by 20%
Contributed to the successful New Drug Application (NDA) for 3 key products
Developed effective change control strategies, resulting in a 15% decrease in project modification time
Resume Worded January 2013 - April 2015
Regulatory Affairs Coordinator
Enhanced filing system for IND applications, resulting in a 10% decrease in retrieval time
Managed Regulatory Documentation for 4 clinical trials successfully
Successfully oversaw the Quality System for medical device production
Resume Worded Institute June 2019 - December 2020
Master of Science - Regulatory Affairs
Completed degree part-time while maintaining full-time employment
Resume Worded University August 2008 - May 2012
Bachelor of Science - Biotechnology
Focus on molecular biology and bioengineering
Cum Laude graduate; active member of regulatory affairs student association
Regulatory Knowledge: FDA regulations, EMA regulations, ICH guidelines, Health Canada regulations, Quality Management Systems (QMS) (ISO 13485)
Technical Skills: MS Office Suite (Expert), SAP (Intermediate), Document Management Systems (DMS) (Proficient)
Industries: Pharmaceuticals, Medical Devices, HealthTech, Biotechnology
Frameworks & Methodologies: Risk Management (ISO 14971), Six Sigma (Green Belt), Good Manufacturing Practice (GMP), Lean Manufacturing
Certifications: Certified Regulatory Affairs Professional (CRAP) – (2018), Six Sigma Green Belt Certification – (2016)
Leadership & Volunteering: Mentor, Regulatory Professionals Society (2017-Present), Volunteer, Medical Relief Non-profit organization (2015 – 2017)
Honours & Awards: Excellence in Regulatory Affairs Award, Johnson & Johnson (2018), Emerging Leader in Regulatory Affairs, Regulatory Affairs Professionals Society (2014)
Continuing Education: Attended Regulatory Affairs Professional Society (RAPS) Convergence Conference (annual, 2013-2019), Completed FDA’s Drug Development Process course (2016)
Your Name
Regulatory Affairs Specialist
City, Country  •  (123) 456-789  •  [email protected]  •
Pfizer March 2019 - Present
Regulatory Affairs Specialist
Expedited drug development timelines by 15% by leading strategic regulatory submissions
Orchestrated the successful Abbreviated New Drug Application (ANDA) for 2 major products
Led team to incorporate FDA regulatory standards effectively in 6 key projects
Masterminded a novel eCTD format, increasing approval rate by 20%
Revised the SOP and saved 100 hours per month in process time April 2014 - February 2019
Regulatory Affairs Consultant
Upheld global/regional CMC regulatory requirements across 7 projects
Spearheaded a team to successful clinical trials and drug approval
Slashed the time to market of 2 pharmaceutical products by 25% through efficient navigation of regulatory requirements
AstraZeneca March 2011 - March 2014
Quality Assurance Specialist
Revamped the GMP and Quality System, leading to a 5% increase in product quality
Ensured accurate regulatory documentation for 4 significant biotechnology projects
Resume Worded University June 2013
Master of Science - Regulatory Affairs
Thesis: 'Optimizing regulatory processes for global pharmaceutical compliance'
Resume Worded Academic Center January 2011
Certificate in Quality Assurance
Specialized in GMP (Good Manufacturing Practices) and ISO 9001 standards
Regulatory Knowledge: FDA Guidelines, EU Guidelines, Pharmaceuticals Legislation, ISO 13485, Medical Device Directives (MDD)
Software and Tools: Microsoft Office Suite (Expert), Regulatory Information Management Systems (RIMS), Veeva Vault RIM, Documentum
Quality Assurance: Quality Management System (QMS), Good Clinical Practices (GCP), Corrective and Preventive Actions (CAPA), Lean Six Sigma methodology
Languages: English (Native), French (Conversational), Spanish (Conversational)
Certifications: Certified Regulatory Affairs Professional, Regulatory Affairs Professionals Society (RAPS)
Continuous Learning: Recently completed online course on 'Advanced Regulatory Affairs for Medical Devices' - Regulatory Affairs Professionals Society (RAPS)
Volunteering: Mentor to 15+ young professionals in Healthcare sector,
Achievements: Recipient of the ‘Top Performer Award’ for Q1 & Q3, Pfizer, 2020
Your Name
Regulatory Affairs Consultant
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded May 2019 - Present
Regulatory Affairs Consultant
Handled diverse regulatory submissions that resulted in the approval of 3 new medical devices
Implemented latest Regulatory Requirements, tipping the approval success rate to 98%
Designed an efficient SOP for eCTD preparation, saving 20 hours weekly
Crucial role in life sciences project that resulted in 2 significant patent applications
Oversaw successful NDA and ANDA of two leading products
Novartis June 2015 - April 2019
Regulatory Affairs Analyst
Spearheaded the regulatory affairs for 4 key clinical trials
Improved IND application processing efficiency by 30% using strategic sorting methods
Implemented GMP leading to an improvement in process efficiency by 15% September 2011 - May 2015
Quality Analyst
Initiated an effective change control system, reducing system glitches by 40%
Dramatically increased quality efficiency by 20% through vigorous overhaul of quality system
Resume Worded Academic Center April 2015
Master’s degree in Pharmaceutical Regulatory Affairs
Special focus on international regulatory framework for pharmaceuticals
Resume Worded University June 2011
Bachelor of Science - Biotechnology
Minors in Biological Sciences and Chemistry
Received the 'Resume Worded Biotech Innovator' award for outstanding research contribution
Regulatory Compliance: ICH Guidelines, FDA Compliance, EU MDR, Risk Management, PMA, 510(k)
Software Proficiency: MS Office Suite, TrackWise, MasterControl, SharePoint, SAP
Process & Quality Assurance: CAPA, SOP Development, Quality Auditing, Process Improvement, Document Control, Validation
Languages: English (Native), Spanish (Conversational), French (Basic)
Certifications: Regulatory Affairs Certification (RAC) - May 2020
Professional Development: Attended Regulatory Affairs Professionals Society (RAPS) Conference - 2018, 2019, 2020
Volunteering: Mentor at BioTech Future Foundation, guiding students interested in Regulatory careers - 2016 to Present
Publications: Co-author of 'Navigating Regulatory Challenges in BioTech Industry', published in Regulatory Focus – December 2020

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

Review the job posting closely.

Go through the Regulatory Affairs Associate posting you're applying to, and identify hard skills the company is looking for. For example, skills like Standard Operating Procedure (SOP), Regulatory Requirements and Regulatory Affairs are possible skills. These are skills you should try to include on your resume.

Add industry skills like U.S. Food and Drug Administration (FDA) and Electronic Common Technical Document (eCTD).

Add other common skills from your industry - such as Biotechnology, Regulatory Submissions and Good Manufacturing Practice (GMP) - into your resume if they're relevant.

Add skills into your work experience.

Incorporate skills - like Quality System, Regulatory Documentation and New Drug Application (NDA) - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Use the exact job title.

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

Word Cloud for Regulatory Affairs Associate Skills & Keywords

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

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Regulatory Affairs Associate 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
Operations Associate (Entry Level Operations Manager)

Resume Example
Sales Associate / Retail Salesperson

Resume Example
Regulatory Affairs Specialist

Resume Example
Regulatory Affairs Manager

Resume Example
Regulatory Affairs Associate (Entry Level)

Resume Example
Sales Associate / Retail Salesperson

Browse Skills from Similar Jobs

Frequently Asked Questions

What skills should you put on a Regulatory Affairs Associate resume?

Some popular Regulatory Affairs Associate hard skills are Regulatory Affairs, Regulatory Submissions, U.S. Food and Drug Administration (FDA), Electronic Common Technical Document (eCTD), Standard Operating Procedure (SOP), Regulatory Requirements, Good Manufacturing Practice (GMP) and Biotechnology.

Depending on the job you apply to, skills like Medical Devices, Drug Development, Quality System, New Drug Application (NDA) and Regulatory Documentation 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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