Regulatory Affairs Specialist | $50-$70/hr Remote
Overview
The Regulatory Affairs Specialist role focuses on shaping AI-driven regulatory documentation by applying deep domain expertise. You’ll work remotely as a contractor, reviewing and refining clinical submissions to align with ICH guidelines and CTD/eCTD standards. This position centers on high quality feedback that guides AI learning, with emphasis on regulatory rigor and clear written communication. What sets this apart is the chance to influence how AI models reason about regulatory challenges using real-world, authoring and review tasks.
What You'll Do6
- 1Draft and critique evaluation tasks modeled after agency requests and sponsor replies to ensure regulatory alignment
- 2Evaluate clinical documentation to verify substantiation, scope of commitments, and regulatory readiness
- 3Identify gaps between what is stated and what is needed, and clearly explain deficiencies with concrete rationale
- 4Check for consistency across large document sets, flagging unsupported or conflicting claims across materials
- 5Provide structured, regulator-focused feedback grounded in applicable guidelines, not subjective impressions
- 6Communicate complex regulatory concepts clearly in both written and verbal forms during asynchronous collaboration
Requirements6
- 1Minimum of 5+ years in regulatory affairs with responsibility for clinical submissions
- 2Experience drafting or leading responses to health authority information requests for ongoing filings
- 3Solid knowledge of ICH guidelines, CTD/eCTD structures, and familiarity with major regulators (FDA, EMA, MHRA, PMDA, Health Canada)
- 4Ability to critically evaluate clinical or safety documents to spot risks and weak statements
- 5Strong written communication skills with the ability to present regulatory reasoning clearly and defensibly
- 6Degree in life sciences, pharmacy, medicine, or related field; RAC certification is a plus
Who Should Apply
Ideal candidates are seasoned regulatory professionals who excel at precise, evidence-based writing and can distill complex regulatory concepts for both humans and AI systems. You should be comfortable working asynchronously, collaborating across regions, and delivering rigorous analysis that withstands regulatory scrutiny.
Salary Insight
Contract role with an hourly rate in the range of $50-$70/hr.
Location
Required Skills
Application Tip
Prepare a concise synthesis of a past health authority response you authored, highlighting how you ensured regulatory alignment and how you would translate that approach for AI-assisted review.
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