Regulatory Affairs Specialist

SaidGig; New York (NY); Remoto; USD 69.000 - 110.000; Part-time

Descrizione del lavoro

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,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory affairs experience

Written communication

Remote collaboration

Critical thinking

Formazione

Life sciences degree

RAC certification (plus)

Strumenti

AI-assisted regulatory tools

Descrizione del lavoro

Apply regulatory affairs expertise to help train next-generation AI systems for regulatory documentation. This remote contract role focuses on evaluating real-world regulatory scenarios and providing rigorous, evidence-based feedback. Prior AI experience is not required.

Key Responsibilities

• Author and review evaluation tasks based on agency requests and sponsor response threads, assessing whether drafted responses meet regulatory expectations.
• Review clinical documentation to determine whether conclusions are supported, commitments are appropriately scoped, and records can withstand regulatory scrutiny.
• Differentiate substantively adequate responses from polished but deficient ones, with clear explanations of identified gaps.
• Evaluate consistency across document sets and identify unsupported or conflicting claims within and between documents.
• Provide structured written feedback grounded in applicable regulatory guidelines.
• Collaborate asynchronously and communicate complex regulatory concepts clearly in writing and verbally.

Qualifications

• 5+ years of direct regulatory affairs experience with a sponsor, CRO, or consultancy, including responsibility for clinical submissions.
• Experience drafting or leading responses to health authority information requests, particularly for active regulatory filings.
• Working knowledge of ICH guidelines, CTD/eCTD structure, and the practical expectations of at least one major regulatory authority, including FDA, EMA, MHRA, PMDA, or Health Canada.
• Ability to critically assess clinical or safety documents for regulatory risks, unsupported statements, and potential reviewer concerns.
• Exceptional written communication, critical-thinking, attention-to-detail, and remote-collaboration skills.
• Degree in life sciences, pharmacy, medicine, or a related discipline; RAC certification is a plus.
• Experience working across multiple regions or agencies, prior health authority reviewer or assessor experience, and familiarity with AI-assisted regulatory tools are valuable.

Work Terms

Remote contract engagement.

Compensation

$50 to $80 per hour.