What skills should a Regulatory Affairs Specialist put on a resume?

O*NET rates Active Listening, Speaking, Writing, Critical Thinking, and Judgment and Decision Making among the most important skills for this occupation. Name the ones that are genuinely yours and show where you used them. A resume that lists skills you do not have is weaker than one that lists fewer.

What software should a Regulatory Affairs Specialist list?

Software recorded for this occupation includes Adobe Acrobat, Analyse-it, Atrion Intelligent Authoring, DataVision, and FileMaker Pro. Applicant tracking systems match on the exact product name, so write the tool as the posting writes it rather than describing it in general terms.

What other job titles cover Regulatory Affairs Specialist work?

O*NET records 26 titles for this occupation, including Regulatory Affairs Associate, RA Associate, Regulatory Affairs Consultant, and RA Consultant. Searching only your own job title hides most of the openings you could apply to.

What qualifications does a Regulatory Affairs Specialist need?

In O*NET's survey of people doing this job, 80% reported their level of education as "Bachelor's Degree". That is what current postholders reported, not a requirement any single employer sets.

Will this resume pass an ATS for a Regulatory Affairs Specialist role?

No tool outside an employer can tell you how that employer's system is configured, including ours. What you can control is that the resume parses cleanly, names the work in the words the posting uses, and does not claim anything you cannot back up.

Regulatory Affairs Specialist resume example

A resume for a Regulatory Affairs Specialist needs to show the work itself: coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. Day to day that means work like this: coordinate efforts associated with the preparation of regulatory documents or submissions; communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Recruiters and applicant tracking systems both read for the tasks and tools this role actually involves, so the strongest resume names them in your own experience rather than describing the job in the abstract. Below are the tasks O*NET records for this occupation, the software and tools it uses, the titles it is advertised under, and the skills worth naming if they are genuinely yours.

Also advertised as

The same job is posted under many titles. Searching only your own job title hides most of the openings you could apply to.

Regulatory Affairs Associate
RA Associate
Regulatory Affairs Consultant
RA Consultant
RA Specialist
Regulatory Engineer
Drug Regulatory Affairs Specialist
Regulatory Affairs Analyst
RA Analyst
Regulatory Affairs Strategist
RA Strategist
Regulatory Services Consultant
Regulatory Specialist
Regulatory Submissions Associate
AML Compliance Analyst
RA Coordinator
Anti Money Laundering Compliance Analyst
Clinical Quality Assurance Associate

O*NET records 26 titles for this occupation in total.

What people in this job call themselves

Titles reported by people actually doing this work, which is often not the title on the job posting.

Regulatory Affairs Analyst (RA Analyst)
Regulatory Affairs Associate (RA Associate)
Regulatory Affairs Consultant (RA Consultant)
Regulatory Affairs Specialist (RA Specialist)
Regulatory Affairs Strategist (RA Strategist)

What this work actually involves

Tasks recorded for this occupation, in O*NET's words. If your experience covers one of these, it belongs on your resume in your own words.

Coordinate efforts associated with the preparation of regulatory documents or submissions.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Coordinate recall or market withdrawal activities as necessary.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Identify relevant guidance documents, international standards, or consensus standards.

30 tasks are recorded in total; these are the most central.

Example bullets for this role

Built from this occupation's own tasks. The brackets stay empty on purpose: we will not invent a number for you, and a fabricated metric is the fastest way to lose an interview you had already won.

Coordinate efforts associated with the preparation of regulatory documents or submissions, for [who or what it served], at [what volume].
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review, for [who or what it served], at [what volume].
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies, for [who or what it served], at [what volume].
Coordinate, prepare, or review regulatory submissions for domestic or international projects, for [who or what it served], at [what volume].

Software used in this role

Recorded for this occupation by O*NET. An applicant tracking system matches the exact product name, so write the tool the way the posting writes it.

Adobe Acrobat
Analyse-it
Atrion Intelligent Authoring
DataVision
FileMaker Pro
Fund accounting software
Healthcare common procedure coding system HCPCS
Human resource management software HRMS
Integrated development environment IDE software
LexisNexis
McAfee
Medical procedure coding software
Microsoft Access
Microsoft Dynamics

34 software entries are recorded in total.

Tools and equipment

The physical equipment this occupation is recorded as using. Worth naming when a posting asks for it by name.

Computer data input scanners
Desktop computers
Laptop computers
Laser facsimile machines
Multi-line telephone systems
Personal computers
Photocopying equipment

Skills an ATS reads for

Worth naming only if they are genuinely yours. Keyword overlap is one input to a resume's score, not a verdict.

Microsoft Dynamics
SQL Server
Microsoft Visual Basic
SAP
SQL
Yardi

What this job rates as most important

O*NET rates every skill for importance to this occupation. These are the highest rated, in order.

01Active Listening
02Speaking
03Writing
04Critical Thinking
05Judgment and Decision Making
06Reading Comprehension
07Complex Problem Solving
08Systems Analysis
09Social Perceptiveness
10Time Management

Knowledge areas

The subject knowledge this occupation draws on, rated by importance.

English Language
Law and Government
Biology
Computers and Electronics
Administration and Management
Administrative

What qualifications people in this job have

From O*NET's survey of people doing this work. This is what postholders reported, not a requirement any single employer sets.

80%Bachelor's Degree
10%Master's Degree
5%Post-Baccalaureate Certificate, awarded for completion of an organized program of study; designed for people who have completed a Baccalaureate degree but do not meet the requirements of academic degrees carrying the title of Master.

What level this role is pitched at

O*NET places this occupation in “Considerable Preparation Needed”. Most of these occupations require a four-year bachelor's degree, but some do not.

A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.

Common questions

What does a Regulatory Affairs Specialist do?: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. Day to day that includes work like coordinate efforts associated with the preparation of regulatory documents or submissions and Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
What skills should a Regulatory Affairs Specialist put on a resume?: O*NET rates Active Listening, Speaking, Writing, Critical Thinking, and Judgment and Decision Making among the most important skills for this occupation. Name the ones that are genuinely yours and show where you used them. A resume that lists skills you do not have is weaker than one that lists fewer.
What software should a Regulatory Affairs Specialist list?: Software recorded for this occupation includes Adobe Acrobat, Analyse-it, Atrion Intelligent Authoring, DataVision, and FileMaker Pro. Applicant tracking systems match on the exact product name, so write the tool as the posting writes it rather than describing it in general terms.
What other job titles cover Regulatory Affairs Specialist work?: O*NET records 26 titles for this occupation, including Regulatory Affairs Associate, RA Associate, Regulatory Affairs Consultant, and RA Consultant. Searching only your own job title hides most of the openings you could apply to.
What qualifications does a Regulatory Affairs Specialist need?: In O*NET's survey of people doing this job, 80% reported their level of education as "Bachelor's Degree". That is what current postholders reported, not a requirement any single employer sets.
Will this resume pass an ATS for a Regulatory Affairs Specialist role?: No tool outside an employer can tell you how that employer's system is configured, including ours. What you can control is that the resume parses cleanly, names the work in the words the posting uses, and does not claim anything you cannot back up.

Related roles

Occupations O*NET records as closest to this one, and worth looking at if this search is not moving.

What this page cannot tell you

No tool outside an employer can tell you how that employer’s ATS is configured, including ours.
This page makes no claim about pay, demand or how many people hold this job. O*NET does not publish that here and we will not estimate it.
Keyword overlap is one input to a resume’s score, not a verdict on you. A resume that names skills you do not have is worse than one that names fewer.

If this is the job you are aiming at, the guide to tailoring a resume covers how to aim one posting properly, and building and exporting a resume here is free.

Occupation data from the O*NET 29.1 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under CC BY 4.0. O*NET is a trademark of USDOL/ETA. SpartanResume is not endorsed by USDOL/ETA.