Regulatory Affairs Specialists

How AI is changing regulatory affairs specialists work

6 of 24 measurable main tasks for this job show up in real AI-use data, so we rate it Amber (some AI use) — 25%. 1 newer task is not in the data yet and left out.

This shows where people already use AI, not whether the job will disappear. How we measure this.

Tasks in this job and recorded AI use

• Prepare responses to customer requests for information (main task) — a lot of recorded AI use
• Interpret regulatory rules or rule changes and make sure that they are communicated through corporate policies and procedures (main task) — some recorded AI use
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues (main task) — some recorded AI use
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards (main task) — some recorded AI use
• Review clinical protocols to make sure collection of data needed for regulatory submissions (main task) — some recorded AI use
• Compile and maintain regulatory documentation databases or systems (main task) — some recorded AI use
• Coordinate, prepare, or review regulatory submissions for domestic or international projects (main task) — no recorded AI use
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review (main task) — no recorded AI use
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (main task) — no recorded AI use
• Review adverse drug reactions and file all related reports following regulatory agency guidelines (main task) — no recorded AI use
• Coordinate efforts associated with the preparation of regulatory documents or submissions (main task) — no recorded AI use
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies (main task) — no recorded AI use
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes (main task) — no recorded AI use
• Prepare or maintain technical files as necessary to obtain and sustain product approval (main task) — no recorded AI use
• Coordinate recall or market withdrawal activities as necessary (main task) — no recorded AI use
• Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors (main task) — no recorded AI use
• Develop regulatory strategies for products (main task) — too new for the AI data
• Identify relevant guidance documents, international standards, or consensus standards (main task) — no recorded AI use
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation (main task) — no recorded AI use
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies (main task) — no recorded AI use
• Participate in internal or external audits (main task) — no recorded AI use
• Recommend changes to company procedures in response to changes in regulations or standards (main task) — no recorded AI use
• Develop or conduct employee regulatory training (main task) — no recorded AI use
• Write or update standard operating procedures, work instructions, or policies (main task) — no recorded AI use
• Develop or track quality metrics (main task) — no recorded AI use
• Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste — some recorded AI use
• Recommend adjudication of product complaints — no recorded AI use
• Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances — no recorded AI use
• Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste — no recorded AI use
• Direct the collection and preparation of laboratory samples as requested by regulatory agencies — no recorded AI use

Tasks: O*NET 31.0. AI use: Anthropic Economic Index (exact or close text match).

Your first steps (guidance)

1. Week 1: Open a free AI assistant and say hello. Follow our “Getting started with AI” guide. Ask it one simple question about your work.
2. Week 2: Use AI on one task you do often. Try the prompt for: “Prepare responses to customer requests for information”. Try the prompt for: “Interpret regulatory rules or rule changes and make sure that they are communicated through corporate policies and procedures”.

Tick your own tasks above to get a plan based on what you really do. The first 2 weeks are free; Premium (coming soon) adds weeks 3–12. New to AI? Read our beginner’s guide.

Questions about AI and regulatory affairs specialists

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