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

O*NET rates Writing, Reading Comprehension, Active Listening, Speaking, and Critical Thinking 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 Manager list?

Software recorded for this occupation includes Adlib Express, Adobe Acrobat, Analyse-it, Aris Global Register, and Axway eSubmissions. 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 Manager work?

O*NET records 21 titles for this occupation, including Compliance Director, Global RA Manager, Global Regulatory Affairs Manager, and RA Director. Searching only your own job title hides most of the openings you could apply to.

What qualifications does a Regulatory Affairs Manager need?

In O*NET's survey of people doing this job, 74% 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 Manager 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 Manager resume example

A resume for a Regulatory Affairs Manager needs to show the work itself: plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. Day to day that means work like this: develop regulatory strategies and implementation plans for the preparation and submission of new products; review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. 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.

Compliance Director
Global RA Manager
Global Regulatory Affairs Manager
RA Director
Regulatory Affairs Director
RA Manager
CMC Director
Global RA Director
Global Regulatory Affairs Director
RA QA Director
RA VP
Regulatory Affairs Vice President
Regulatory Director
Vaccine RA Director
Vaccine Regulatory Affairs Director
CMC Regulatory Affairs Manager
RA and Compliance Director
Regulatory Affairs and Compliance Director

O*NET records 21 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.

CMC Director (Chemistry, Manufacturing, and Controls Director)
Global RA Director (Global Regulatory Affairs Director)
Global RA Manager (Global Regulatory Affairs Manager)
RA Director (Regulatory Affairs Director)
RA Manager (Regulatory Affairs Manager)
RA QA Director (Regulatory Affairs Quality Assurance Director)
RA VP (Regulatory Affairs Vice President)
Vaccine RA Director (Vaccine Regulatory Affairs Director)

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.

Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Provide responses to regulatory agencies regarding product information or issues.
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Maintain current knowledge of relevant regulations, including proposed and final rules.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

27 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.

Develop regulatory strategies and implementation plans for the preparation and submission of new products, for [who or what it served], at [what volume].
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards, for [who or what it served], at [what volume].
Direct the preparation and submission of regulatory agency applications, reports, or correspondence, for [who or what it served], at [what volume].
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary, 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.

Adlib Express
Adobe Acrobat
Analyse-it
Aris Global Register
Axway eSubmissions
Database software
Datafarm a-Pulse
Datafarm eCTDGatekeeper
Datafarm eCTDViewer
Datafarm S-Cubed
Dialog DialogLink
Document publishing software
DoubleBridge ROSETTA Phoenix eCTD Viewer
DoubleBridge ROSETTA Pyramid

69 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 laser printers
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.

Adlib Express
Analyse-it

What this job rates as most important

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

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

Knowledge areas

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

English Language
Law and Government
Administration and Management
Biology
Education and Training
Administrative
Chemistry

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.

74%Bachelor's Degree
13%Master's Degree
4%Some College Courses

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 Manager do?: Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. Day to day that includes work like develop regulatory strategies and implementation plans for the preparation and submission of new products and Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
What skills should a Regulatory Affairs Manager put on a resume?: O*NET rates Writing, Reading Comprehension, Active Listening, Speaking, and Critical Thinking 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 Manager list?: Software recorded for this occupation includes Adlib Express, Adobe Acrobat, Analyse-it, Aris Global Register, and Axway eSubmissions. 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 Manager work?: O*NET records 21 titles for this occupation, including Compliance Director, Global RA Manager, Global Regulatory Affairs Manager, and RA Director. Searching only your own job title hides most of the openings you could apply to.
What qualifications does a Regulatory Affairs Manager need?: In O*NET's survey of people doing this job, 74% 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 Manager 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.