Talent.com
Micro1
Remote Regulatory Affairs SpecialistMicro1 • Prosper, Texas, US
No longer accepting applications
Remote Regulatory Affairs Specialist

Remote Regulatory Affairs Specialist

Micro1 • Prosper, Texas, US
22 days ago
Salary
$50.00 hourly
Job type
  • Full-time
  • Remote
Job description
Regulatory Affairs Specialist$50 - $70/hourpay

Required Skills

regulatory affairsclinical documentation reviewich guidelinesctd/ectd structurewritten communicationcritical thinkingregulatory submissionshealth authority interactionsattention to detailremote collaboration

About micro1

micro1 is the leading AI data lab for training frontier models and evaluating AI agents. Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more. micro1 transforms that real-world expertise into high-quality training data, evaluations, and feedback loops that improve how AI systems learn, reason, and perform.

Our platform identifies and vets top talent through an AI recruiter, enabling high-quality expert contributions at scale. We aim to enable 1 billion people to do meaningful work by applying their expertise to AI. As our global expert network grows, micro1 is building the human intelligence layer for frontier AI.

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).
Create a job alert for this search

Remote Regulatory Affairs Specialist • Prosper, Texas, US

Similar jobs

Regulatory Affairs Specialist 2

Marmon Holdings, Inc.Addison, TX, United States
Full-time

Regulatory Affairs SpecialistAs a part of the global industrial organization Marmon Holdingswhich is backed by Berkshire Hathawayyou'll be doing things that matter, leading at every level, and winn... Show more

 • Promoted

Regulatory Affairs Specialist 3

Cedent Life TalentAddison, TX, United States
Full-time

Regulatory Affairs Specialist 3.The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle.Relies on exten... Show more

 • Promoted

Retail Tax Expert

IntuitProsper, TX, United States
Full-time

Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States.... Show more

 • Promoted • New!

Senior Tax Expert Retail

IntuitProsper, TX, United States
Full-time

Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States.... Show more

 • Promoted

Regulatory Affairs Specialist 3

Marmon Holdings, Inc.Addison, TX, United States
Full-time

The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle.Relies on extensive experience and judgment to ... Show more

 • Promoted

Senior Specialist, Contracts

L3Harris TechnologiesPlano, TX, United States
Full-time

Our team is actively seeking a Contracts Senior Specialist to join the Intelligence, Surveillance and Reconnaissance (ISR) business area.This position is responsible for a diverse business area, wi... Show more

 • Promoted

Infection Prevention and Control Technical Specialist - Remote

TradeJobsWorkForce75225 University Park, TX, US
Remote
Full-time

Infection Prevention and Control Technical Specialst Job Duties: Consolidate, review and revise Americares existing technical materials related to disease outb... Show more

 • Promoted

Manager, Cyber Audit and Regulatory Engagements

Capital OnePlano, TX, United States
Full-time +1

Manager, Cyber Audit and Regulatory Engagements.As a Manager of Cyber Audits and Exams at Capital One, you will work closely across the Cybersecurity organization to coordinate and execute on audit... Show more

 • Promoted

Independent Client Services Consultant (Remote)

Travel with LaniMckinney, TX, United States
Remote
Full-time

Independent Client Services Consultant (Remote).We are bringing on Independent Client Services Consultant (Remote) to join our remote team.You will assist clients with planning, booking, and suppor... Show more

 • Promoted

Regulatory Compliance Specialist

SRS DistributionAllen, TX, United States
Full-time

Regulatory Compliance SpecialistThe position of Regulatory Compliance Specialist is centered on ensuring adherence to pertinent local, state, and federal regulations by collaborating closely with t... Show more

 • Promoted

Manager, Regulatory Affairs and Compliance

NordsonAllen, TX, United States
Full-time

Quality & Regulatory Affairs Manager.Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individua... Show more

 • Promoted

Manager, Regulatory Compliance (Remote)

Globe Life Family of CompaniesMc Kinney, TX, United States
Remote
Full-time +1

Job DescriptionAt Globe Life, we are committed to empowering our employees with the support and opportunities they need to succeed at every stage of their career.Our thriving and dynamic community ... Show more

 • Promoted

Regulatory Manager - Remote

StaffingAllen, TX, United States
Remote
Full-time

Location: Remote or Allen, TX Duration: 12 months.Interpret, summarize and communicate local, state and federal broadband grant program guiding principles, rules and regulation.Ensure compliance of... Show more

 • Promoted

Bilingual Tax Preparation Specialist - Richardson TX

Lopez Auto Insurance and TaxRichardson, TX, United States
Full-time

Bilingual Tax Preparation Specialist.Join our team as a Bilingual Tax Preparation Specialist, where you'll make an impact by guiding clients through accurate and compliant tax filing.You'll use you... Show more

 • Promoted

Regional Director of Laboratory Services

Baylor University Medical CenterPlano, TX, United States
Full-time

Regional Director of Laboratory Services.Regional Director of Laboratory Services is responsible for planning, directing, and coordinating operations and programs of laboratory services at Baylor S... Show more

 • Promoted

Regulatory Manager - Remote

Georgia IT, Inc.Allen, TX, United States
Remote
Full-time

Location: Remote or Allen, TX Duration: 12 months.Interpret, summarize and communicate local, state and federal broadband grant program guiding principles, rules and regulation.Ensure compliance of... Show more

 • Promoted

Regulatory Manager - HVAC (Remote)

TTE Technology IncPlano, TX, United States
Remote
Full-time

Job DescriptionJob DescriptionPosition Summary :At TCL North America, innovation powers every product we create-including our rapidly expanding HVAC solutions.As a global leader in consumer technol... Show more

 • Promoted

Remote Product Tester - Flexible Studies

BuzzTestersHowe, TX
Remote
Full-time

Earn up to $400/week, depending on the number and type of studies you complete.Share honest feedback on products and services from independent brands.Assignments include short online surveys (10–20... Show more

 • Promoted

Tax Professional Retail

IntuitProsper, TX, United States
Full-time

Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States.... Show more

 • Promoted

Bilingual Tax Preparation Specialist

Lopez Auto Insurance and TaxGarland, TX, United States
Full-time

Bilingual Tax Preparation Specialist.Join our team as a Bilingual Tax Preparation Specialist, where you'll make an impact by guiding clients through accurate and compliant tax filing.You'll use you... Show more