AI-Focused Regulatory Affairs Specialist (Remote)

SaidGig; New York (NY); Remote; USD 69,000 - 110,000; Part time

Job summary

SaidGig is seeking a regulatory affairs expert to help train AI systems for regulatory documentation in a remote contract role. You will evaluate real-world regulatory scenarios and provide rigorous, evidence-based feedback with no required AI background.

The position emphasizes precise, well-structured responses to agency requests and strong cross-functional communication. The ideal candidate has 5+ years in regulatory affairs, familiarity with ICH guidelines, CTD/eCTD, and major authorities,

Qualifications

• 5+ years of regulatory affairs experience with a sponsor, CRO, or consultancy.
• Experience drafting responses to health authority information requests.
• Knowledge of ICH guidelines, CTD/eCTD structure, and major authorities (FDA, EMA, MHRA, PMDA, Health Canada).
• Ability to assess clinical/safety documents for regulatory risks and reviewer concerns.
• Exceptional written communication and remote-collaboration skills.
• Life sciences degree; RAC certification is a plus.
• Experience across regions/agencies and familiarity with AI-assisted tools.

Responsibilities

• Author and review evaluation tasks based on agency requests and sponsor responses.
• Review clinical documentation to ensure conclusions are supported and records withstand scrutiny.
• Identify gaps between drafted responses and regulatory expectations.
• Evaluate consistency across document sets and flag unsupported claims.
• Provide structured written feedback grounded in regulator guidelines.
• Collaborate asynchronously and communicate complex concepts clearly in writing and verbally.

Skills

Regulatory affairs experience

Written communication

Remote collaboration

Critical thinking

Education

Life sciences degree

RAC certification (plus)

Tools

AI-assisted regulatory tools

Job description

SaidGig is seeking a regulatory affairs expert to help train AI systems for regulatory documentation in a remote contract role. You will evaluate real-world regulatory scenarios and provide rigorous, evidence-based feedback with no required AI background.

The position emphasizes precise, well-structured responses to agency requests and strong cross-functional communication. The ideal candidate has 5+ years in regulatory affairs, familiarity with ICH guidelines, CTD/eCTD, and major authorities,