Distribution across 20 profiles.
Middle half of Regulatory Affairs Specialists score between 29% and 34%.
0%
50%
100%
p10 · 28%
35% · p90
Task breakdown by work type
On-screen work79%
Done entirely on a computer. High AI exposure — these tasks are already in the automation zone.
In-person + screen0%
Physical sensing, digital output — e.g. interviewing someone then writing a report. Partially protected.
Computer + action0%
Computer input, real-world output — needs someone to act on it, not just software.
Fully in-person21%
No computer required. Furthest from automation — the strongest human advantage.
Typical tasks
3 synthetic profiles for a Regulatory Affairs Specialist, ordered by automation exposure.
Tab between them to see how task mix drives the score difference.
TaskTimeTypeExposure
Drafting and preparing regulatory submissions (dossiers, CTDs, IND applications, meeting briefing packages) for submission to authorities
deep expertisesocial element
37%DD
34%
Advising senior leadership and product teams on regulatory strategy, risk assessment, and feasibility of proposed development or market approaches
deep expertisesocial core
32%AA
6%
Reviewing and interpreting regulatory requirements from FDA, EMA, or other agencies; extracting compliance obligations from guidance documents and regulations
deep expertise
11%DD
34%
Responding to regulatory agency questions, requests for additional information (RFIs), and managing correspondence with inspectors or review divisions
deep expertisesocial element
10%DD
29%
Monitoring regulatory landscape changes, tracking new guidance documents, policy shifts, and legislative updates relevant to company products
4%DD
48%
Coordinating with internal teams (R&D, Quality, Medical, Marketing) to gather data, align strategies, and ensure submissions meet both regulatory and business needs
deep expertisesocial core
2%AA
4%
Maintaining regulatory databases and tracking systems; updating submission timelines, approval status, and compliance calendars
1%DD
88%
TaskTimeTypeExposure
Drafting and preparing regulatory submissions (dossiers, CTDs, IND applications, meeting briefing packages) for submission to authorities
31%DD
45%
Reviewing and interpreting regulatory requirements from FDA, EMA, or other agencies; extracting compliance obligations from guidance documents and regulations
deep expertise
25%DD
28%
Monitoring regulatory landscape changes, tracking new guidance documents, policy shifts, and legislative updates relevant to company products
18%DD
48%
Coordinating with internal teams (R&D, Quality, Medical, Marketing) to gather data, align strategies, and ensure submissions meet both regulatory and business needs
deep expertisesocial core
13%AA
3%
Responding to regulatory agency questions, requests for additional information (RFIs), and managing correspondence with inspectors or review divisions
deep expertisesocial core
6%DD
21%
Advising senior leadership and product teams on regulatory strategy, risk assessment, and feasibility of proposed development or market approaches
deep expertisesocial core
3%AA
0%
Maintaining regulatory databases and tracking systems; updating submission timelines, approval status, and compliance calendars
1%DD
62%
TaskTimeTypeExposure
Reviewing and interpreting regulatory requirements from FDA, EMA, or other agencies; extracting compliance obligations from guidance documents and regulations
21%DD
56%
Drafting and preparing regulatory submissions (dossiers, CTDs, IND applications, meeting briefing packages) for submission to authorities
deep expertisesocial element
18%DD
27%
Coordinating with internal teams (R&D, Quality, Medical, Marketing) to gather data, align strategies, and ensure submissions meet both regulatory and business needs
deep expertisesocial core
17%AA
6%
Responding to regulatory agency questions, requests for additional information (RFIs), and managing correspondence with inspectors or review divisions
deep expertisesocial core
17%DD
16%
Maintaining regulatory databases and tracking systems; updating submission timelines, approval status, and compliance calendars
10%DD
85%
Monitoring regulatory landscape changes, tracking new guidance documents, policy shifts, and legislative updates relevant to company products
10%DD
50%
Advising senior leadership and product teams on regulatory strategy, risk assessment, and feasibility of proposed development or market approaches
deep expertisesocial core
3%AA
5%
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AI tools for this role
Tools relevant to the most automatable tasks in this profession.
