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How exposed to AI is a Regulatory Affairs Manager?

Of the 27 tasks O*NET lists for regulatory affairs managers, 5 could be done in half the time with a chat window today. 3 cannot be sped up at all. Here is which.

Exposure means published research judged an AI could halve the time a task takes, at the same quality. It does not mean the task stops needing a person. How to read this

Also called
CMC Director (Chemistry, Manufacturing, and Controls Director)Compliance DirectorGlobal 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)Regulatory DirectorVaccine RA Director (Vaccine Regulatory Affairs Director)
Reachable today Needs software built first Cannot be sped up
27
tasks rated for this occupation
96%
hold a degree, from a survey of 23
498k
people do this job in the US
5 of 56
least protected in management

Every task, and what AI can do with it

These are O*NET's task statements for this occupation, exactly as written, sorted into the three bands by the ratings behind this report. Nothing has been reworded.

Reachable with a chat window today

5
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products
  • Participate in the development or implementation of clinical trial protocols

Only with software built on top

19
  • Provide responses to regulatory agencies regarding product information or issues
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
  • Train staff in regulatory policies or procedures
  • Develop and maintain standard operating procedures or local working practices
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
  • Contribute to the development or implementation of business unit strategic and operating plans
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats
  • Coordinate internal discoveries and depositions with legal department staff
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations
  • Establish regulatory priorities or budgets and allocate resources and workloads
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions
  • Monitor regulatory affairs trends related to environmental issues
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation

Cannot be sped up

3
  • Manage activities such as audits, regulatory agency inspections, or product recalls
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives
What this does not say

This is not a prediction about your job

Nobody surveyed an employer. Tasks are counted equally, so a percentage here is a share of the list rather than a share of your week. And the ratings were made in 2023, which makes every figure a floor rather than a ceiling.

It must never be used to select anyone for redundancy. The full limits are here.

Where to go next

This is the standard task list for the title. The useful next question is which of the tasks you actually do should go near AI, and which should not.

Sort your own tasks Read the full report

Exposure ratings from Eloundou, Manning, Mishkin and Rock, GPTs are GPTs: Labor market impact potential of LLMs, Science 384, 1306–1308, 2024, used under the MIT licence. This page includes information from the O*NET Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. O*NET® is a trademark of USDOL/ETA. People Team AI has modified all or some of this information. USDOL/ETA has not approved, endorsed, or tested these modifications. Employment figures from the US Bureau of Labor Statistics.