Business and Financial Operations · Holland code CEI

Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Also called: RA Associate (Regulatory Affairs Associate), RA Consultant (Regulatory Affairs Consultant), Regulatory Consultant, Regulatory Specialist, Drug Regulatory Affairs Specialist, QA Specialist (Quality Assurance Specialist), RA Analyst (Regulatory Affairs Analyst), RA Strategist (Regulatory Affairs Strategist).

O*NET 13-1041.07

At a glance

US median annual pay: $80,730; Middle half earn $61,280 to $109,010. BLS OEWS, May 2025.
Most common education: Bachelor's Degree; 80% of workers surveyed by O*NET report this level.
Preparation needed: Job Zone 4 of 5; Considerable preparation. Zone 1 is little or none; zone 5 is graduate-level.
US employment outlook, 2024 to 2034: +3% · As fast as average; 418,000 jobs in 2024, projected 430,300. BLS Occupational Outlook Handbook, which groups this with similar roles as "Compliance officers".

What the work involves

The tasks workers in this occupation rate as most important, from the O*NET survey.

Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Prepare or maintain technical files as necessary to obtain and sustain product approval.

Skills and knowledge it leans on

Skills

Reading Comprehension4.0 / 5
Active Listening4.0 / 5
Writing4.0 / 5
Speaking4.0 / 5
Critical Thinking4.0 / 5
Active Learning3.8 / 5

Knowledge areas

English Language4.2 / 5
Law and Government3.9 / 5
Administration and Management3.4 / 5
Administrative3.2 / 5
Computers and Electronics3.2 / 5
Medicine and Dentistry2.7 / 5

Importance ratings on O*NET’s 1 to 5 scale. Higher means the occupation depends on it more.

Who tends to enjoy it

How strongly this occupation draws on each of the six Holland interest types, which is the same profile the career interests test compares you against.

Realistic7
Investigative39
Artistic0
Social25
Enterprising58
Conventional89

The same work abroad

Other countries classify jobs differently, so these are the closest matches through the international ISCO-08 standard, not exact equivalents.

European occupation titles (ESCO)

licensing manager · DE Zulassungsmanager/Zulassungsmanagerin · FR directeur des licences/directrices des licences
toxicologist · DE Toxikologe/Toxikologin · FR toxicologue
pharmaceutical engineer · DE Ingenieur Pharmatechnik/Ingenieurin Pharmatechnik · FR ingénieur procédés pharmaceutiques/ingénieure procédés pharmaceutiques
compliance engineer · DE Compliance-Ingenieur/Compliance-Ingenieurin · FR responsable qualité conformité réglementaire
pharmaceutical quality specialist · DE Qualitätsprüfer Arzneimittel/Qualitätsprüferin Arzneimittel · FR pharmacien en pharmacovigilance/pharmacienne en pharmacovigilance
regulatory affairs manager · DE Regulatory-Affairs-Manager/Regulatory-Affairs-Managerin · FR chef de service juridique

Closest UK occupation groups (SOC 2020)

Natural and social science professionals n.e.c. (2119)36,500 employed
Pharmacists (2251)80,400 employed
Inspectors of standards and regulations (3581)44,300 employed

Employment is the UK Annual Population Survey for April 2025 to March 2026, all workers in the group, which can be broader than this one occupation.

Pay across Europe, for the whole group

Median annual earnings of all employees in “Professionals”. This is the broad ISCO group this occupation falls in, not the occupation itself, so treat it as context for the wage level, not as a salary for this job.

Median annual earnings, Professionals, by country
Country	Median pay
Belgium	€61,714
Germany	€59,529
Ireland	€56,877
Austria	€55,374
Netherlands	€53,595
Sweden	€43,567
France	€41,515
Spain	€35,735
Italy	€33,649
Portugal	€26,072
Poland	€14,380

Eurostat Structure of Earnings Survey, businesses with ten or more employees outside public administration, in euro and not adjusted for the cost of living. Reference years differ between sources: the US, Japan and Europe figures on this page come from different survey years, so compare them as rough levels, not to the euro or yen.

Exposure to AI

This occupation sits in the middle third of the 774 occupations scored, with an exposure score of +0.70. The scores are standardized across those occupations, so 0 is the average and a score of 1 is about one standard deviation above it.

Our note on reading it: the dataset links AI applications to the abilities that occupations require, so the score reflects overlap between the two. It is a comparison between occupations, not a forecast about jobs. It does not say whether exposure means tasks are replaced or workers get more done with the tools, and it says little about one employer or one role.

Source: Felten, E., Raj, M., & Seamans, R. (2021). Occupational, industry, and geographic exposure to artificial intelligence: A novel dataset and its potential uses. Strategic Management Journal, 42(12), 2195-2217. Matched to this page by 6-digit SOC code (13-1041).

Is it a fit for you?

Interest is one input, alongside ability, pay and what is hiring near you. The career interests test takes about thirteen minutes and ranks occupations by how closely their profile matches yours.

Take the career interests test