Regulatory Affairs Analyst

Regulatory Affairs Analyst delivers the hands-on work summarized here and you can explore 20 real tasks. Profiles show time makeup and who benefits directly from each action. Each one shows where we found it, and comes with an AI prompt you can copy and use straight away.

20evidenced tasks
20ready prompts
7tools of the trade
13-1041.07O*NET-SOC code
417,070hold this job (US, BLS 2025)
$80,730median pay/yr (US)
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What it pays

Government survey numbers — not estimates, not ads.

Half of all Compliance Officers in the U.S. earn more than $80,730 a year — the middle 80% land between $48,220 and $133,720. About 417,070 people in the U.S. do this work. Figures are for the U.S. occupation group “Compliance Officers”. (U.S. Bureau of Labor Statistics survey, published 2025.) In India, Professionals earn about ₹38,298 a month on average — around ₹4.6 lakh a year (government PLFS survey via ILOSTAT, occupation-family figure).
$80,730typical pay / year
417,070people in this work
$133,720+top 10% earn
₹4.6 lakha year in India (family avg)
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The work, task by task

These are the real jobs-to-be-done, not a wish list. Each task shows where we found it, and the prompt underneath is written for that exact task.

Keeping the record2

Support submission of regulatory documentation

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Compile the clinical study reports, device descriptions, and the current risk management file, cross-check…
Compile the clinical study reports, device descriptions, and the current risk management file, cross-check them against the latest internal submission checklist, assemble a single submission packet, and upload it to the regulatory dossier workspace for the submission coordinator by Wednesday noon.
The tools that do the workMicrosoft SharePointMicrosoft Wordjob descriptionsO*NET

Represent company during inspections and meetings

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Draft the inspection briefing with the product history, key compliance metrics, open CAPAs and the inspection…
Draft the inspection briefing with the product history, key compliance metrics, open CAPAs and the inspection team contact list, rehearse answers with QA and manufacturing, then present the briefing to the inspector and log all questions and agreed actions on the inspection record.
The tools that do the workMicrosoft PowerPointMicrosoft Wordjob descriptionsO*NET
Protecting2

Interpret and stay updated on regulations

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Review the two newest guidance documents from the regulator, extract obligations affecting labeling and…
Review the two newest guidance documents from the regulator, extract obligations affecting labeling and post-market surveillance, annotate a one-page summary of required actions and dates, and circulate it to QA, labeling, and the regulatory lead by end of day Friday.
The tools that do the workMicrosoft WordMicrosoft Outlookjob descriptionsO*NET

Participate in internal or external audits.

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Prepare the audit evidence package by pulling controlled SOPs, change logs, training records and batch…
Prepare the audit evidence package by pulling controlled SOPs, change logs, training records and batch release documents for the last 12 months, map each item to the audit checklist, and deliver the organised folder to the lead auditor two days before the audit start.
The tools that do the workMicrosoft ExcelMicrosoft SharePointjob descriptionsO*NET
The daily work16

Coordinate recall or market withdrawal activities as necessary.

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Coordinate an immediate recall or market withdrawal for Lot 4321: confirm scope with Quality, draft the…
Coordinate an immediate recall or market withdrawal for Lot 4321: confirm scope with Quality, draft the customer notification and distributor instructions, assemble the batch trace and adverse event logs, and set a timeline to notify regulators by close of business Friday.
The tools that do the workMicrosoft WordMicrosoft OutlookO*NET

Recommend adjudication of product complaints.

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Review Complaint 2026-119 and recommend adjudication: determine if complaint meets reportable criteria,…
Review Complaint 2026-119 and recommend adjudication: determine if complaint meets reportable criteria, propose classification, attach supporting test results and CAPA status, and send recommendation to the complaint review board by Wednesday morning.
The tools that do the workMicrosoft ExcelMicrosoft WordO*NET

Identify relevant guidance documents, international standards, or consensus standards.

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Identify current guidance and standards for nasal spray devices sold in EU and UK: collect applicable…
Identify current guidance and standards for nasal spray devices sold in EU and UK: collect applicable guidance, ISO standards, and recent regulator notices, annotate relevance to our device claims, and compile a one-page impact summary for Regulatory by Tuesday.
The tools that do the workMicrosoft SharePointMicrosoft WordO*NET
km/h RPM

Develop or track quality metrics.

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Develop monthly quality metrics dashboard: agree KPIs with Quality and Manufacturing, define data sources and…
Develop monthly quality metrics dashboard: agree KPIs with Quality and Manufacturing, define data sources and calculation rules, build the dashboard that updates each week, and circulate the first report to the leadership team next Monday.
The tools that do the workMicrosoft ExcelMicrosoft PowerPointO*NET

Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.

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Determine applicable regulations for packaging waste management in Germany and France for our overwraps: list…
Determine applicable regulations for packaging waste management in Germany and France for our overwraps: list producer responsibilities, collection and recycling targets, documentation requirements, and recommend changes to our supplier contracts by end of month.
The tools that do the workMicrosoft WordMicrosoft ExcelO*NET

Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.

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Lead regulatory review for green biotech crop dossier: map national approval pathways for cultivation in…
Lead regulatory review for green biotech crop dossier: map national approval pathways for cultivation in Brazil and Argentina, flag post-market monitoring obligations, compile required study types and timelines, and deliver a regulatory strategy memo to R&D by Friday.
The tools that do the workMicrosoft WordMicrosoft ExcelO*NET

Organisational policies

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Update the organisational policy manual to reflect the new record-keeping requirements, review each policy…
Update the organisational policy manual to reflect the new record-keeping requirements, review each policy for gaps against the compliance checklist, add an executive summary of changes, and circulate the revised manual to Legal and HR for sign-off by Friday.
The tools that do the workMicrosoft WordMicrosoft OutlookESCOsee the evidence ↗

Ensure compliance with policies

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Run a compliance sweep of current operational policies against the regulatory checklist, flag any…
Run a compliance sweep of current operational policies against the regulatory checklist, flag any non-conforming clauses with recommended wording, prepare a brief report of high-risk items, and send it to the compliance manager and operations lead for action within three working days.
The tools that do the workMicrosoft ExcelMicrosoft OutlookESCOsee the evidence ↗

Business analysis

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Analyse last six months of policy change requests and incident logs to identify recurring gaps, produce a…
Analyse last six months of policy change requests and incident logs to identify recurring gaps, produce a one-page business case for two corrective projects with estimated resource impact, and present the case to the regulatory steering group next Tuesday.
The tools that do the workMicrosoft ExcelMicrosoft PowerPointESCOsee the evidence ↗

Ensure compliance with legal requirements

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Cross-check our product labelling and submission timelines against the updated statutory requirements, list…
Cross-check our product labelling and submission timelines against the updated statutory requirements, list any non-compliant items with the clause reference and required corrective action, and escalate unresolved issues to Legal and the product manager by close of business Thursday.
The tools that do the workMicrosoft WordMicrosoft SharePointESCOsee the evidence ↗

Manage compliance documentation and reports

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Gather the last 12 months of compliance filings, update the master compliance register with current statuses…
Gather the last 12 months of compliance filings, update the master compliance register with current statuses and owners, attach the supporting certificates and send a status brief to Zoe in legal and to Carl in operations by Thursday close of business.
The tools that do the workMicrosoft ExcelMicrosoft Outlookjob descriptions

Monitor and interpret regulations from agencies like EPA, OSHA

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Track newly published rules from EPA and OSHA for the past two weeks, summarise material changes and…
Track newly published rules from EPA and OSHA for the past two weeks, summarise material changes and immediate action items in a one‑page memo, and send it to Priya in environmental affairs and to my manager by Tuesday morning.
The tools that do the workMicrosoft WordMicrosoft Outlookjob descriptions

Conduct risk assessments and develop mitigation plans

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Run the risk scoring template for the label change project, populate likelihood and consequence ratings,…
Run the risk scoring template for the label change project, populate likelihood and consequence ratings, propose three mitigation steps for the top three risks, and circulate the assessment to Hannah in product safety and to me for approval by Friday noon.
The tools that do the workMicrosoft ExcelMicrosoft Wordjob descriptions

Oversee the development of products and services from inception to market release

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Create a milestone map from concept through market release for the inhaler line, flag regulatory decision…
Create a milestone map from concept through market release for the inhaler line, flag regulatory decision points and required submissions, assign owners and deadlines, then share the map with product, clinical and supply chain by Wednesday end of day.
The tools that do the workMicrosoft ProjectMicrosoft VisioESCO

Meet regulatory requirements

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Compile the checklist of applicable regulations and required evidence for the new packaging, confirm gaps…
Compile the checklist of applicable regulations and required evidence for the new packaging, confirm gaps with quality and procurement, and upload the completed checklist to the team library before the Friday review meeting.
The tools that do the workMicrosoft SharePointMicrosoft WordESCO

Ensure products and services meet regulatory requirements

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Review the product spec and regulatory matrix for the upcoming launch, verify each requirement has test…
Review the product spec and regulatory matrix for the upcoming launch, verify each requirement has test evidence or a mitigation, prepare a nonconformance log for any gaps, and send it to Rachel in quality and to the program lead by Monday morning.
The tools that do the workMicrosoft ExcelMicrosoft OutlookESCO

Says who?

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