Talent.com
Micro1
Remote Regulatory Affairs SpecialistMicro1 • Roswell, Georgia, US
Remote Regulatory Affairs Specialist

Remote Regulatory Affairs Specialist

Micro1 • Roswell, Georgia, US
9 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 • Roswell, Georgia, US

Similar jobs

Global Regulatory Affairs Device Lead, (Raleigh, NC)

UCBAtlanta, GA, United States
Full-time

Global Regulatory Affairs Devices Lead (GRA-DL)Make your mark for patientsAre you ready to shape the future of cutting-edge medical technologies? As the Global Regulatory Affairs Devices Lead (GRA-... Show more

 • Promoted

Senior Regulatory Affairs Manager (Onsite)

CorDxAtlanta, GA, United States
Full-time

Senior Regulatory Affairs ManagerCorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.With over 2,100 employees across the world, serv... Show more

 • Promoted

Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesAtlanta, GA, United States
Full-time

In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulat... Show more

 • Promoted

Sr. Regulatory Affairs Specialist II

Katalyst Healthcares & Life SciencesAtlanta, GA, United States
Full-time

This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.Europe, support of international product registrations and related regula... Show more

 • Promoted

Regulatory Affairs Specialist

CorDxAlpharetta, GA, United States
Full-time

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health.With over 2000 employees across the world serving millions of users in over 100... Show more

 • Promoted

Director, Regulatory Compliance & Nutrition

Inspire Brands, Inc.Atlanta, GA, United States
Full-time

Director, Regulatory Compliance & Nutrition.The Director, Regulatory Compliance & Nutrition is responsible for defining and leading the enterprise-wide strategy, governance, and execution of regula... Show more

 • Promoted

Regulatory Reporting Manager

DeloitteAtlanta, GA, United States
Full-time

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Regulatory Reporting Manager you will have the ability to share new idea... Show more

 • Promoted

Consultant, Rates & Regulatory

Black & VeatchAtlanta, GA, United States
Full-time

Consultant, Rates & Regulatory.Together, we own our company, our future, and our shared success.As an employee-owned company, our people are Black & Veatch.We put them at the center of everything w... Show more

 • Promoted

Compliance Specialist

CopperPoint Insurance CompaniesAtlanta, GA, United States
Full-time

CopperPoint has an exciting opportunity for a Compliance Specialist.In this role, you'll help develop and administer an effective regulatory compliance program that ensures adherence to state regul... Show more

 • Promoted

Senior Regulatory & Filings Analyst-Legal

AmTrust Financial ServicesAlpharetta, GA, United States
Full-time

Leads end-to-end regulatory filing strategy and execution for property and specialty risk insurance products across multiple U.Provides advanced regulatory analysis, interpreting complex statutes, ... Show more

 • Promoted

1940 Act Regulatory Administration Manager

U.S. BancorpAtlanta, GA, United States
Full-time

Regulatory Administration Group Member.The Regulatory Administration group supports fund clients through preparation of registered investment company regulatory filings, fund governance documents, ... Show more

 • Promoted

Remote Regulatory Affairs contractor

GlobalchannelmanagementAtlanta, Georgia, United States
Remote
Full-time
Quick Apply

Remote Regulatory Affairs contractor requires:.Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field.Proven experience preparing, writing and submitting FDA ... Show more

Risk & Regulatory Consultant-Buffalo, NY

StaffingAlpharetta, GA, United States
Full-time

Location: Buffalo, NY Rate: DOE $110k/Yr.Benefits Position Type: Full Time Interview Process: Phone Followed by F2F.US Citizen, Green Card and GC EAD.Job Description: 14+ years of experience in te... Show more

 • Promoted

Manager-Regulatory Business-Utilities

Testa Search PartnersAtlanta, GA, United States
Full-time

Our client is seeking a remote Manager, Regulatory Business, under the direction of the Sr.Director Regulatory Business, prepares data in support of utility water/wastewater rate and regulatory fil... Show more

 • Promoted

Regulatory Affairs Specialist (North America)

AlimentivAtlanta, GA, United States
Full-time

Global Regulatory Affairs Specialist.Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.Role will include management of clinical trial applications... Show more

 • Promoted

Regulatory Affairs Manager (Atlanta)

CorDxAtlanta, GA, United States
Full-time

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requireme... Show more

 • Promoted

Risk & Regulatory Consultant-Buffalo, NY

Georgia IT, Inc.Alpharetta, GA, United States
Full-time

Location: Buffalo, NY Rate: DOE $110k/Yr.Benefits Position Type: Full Time Interview Process: Phone Followed by F2F.US Citizen, Green Card and GC EAD.Experience of working with top executives and d... Show more

 • Promoted

Sr. Regulatory Professional

Avery Healthcare Group Ltd.Atlanta, GA, United States
Full-time

Regulatory Companion Diagnostics Professional.This is an exciting opportunity to be part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of ... Show more

 • Promoted

Senior Regulatory Affairs Specialist II

Katalyst Healthcares & Life SciencesAtlanta, GA, United States
Full-time

Job TitleThis position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.Europe, support of international product registrations and relat... Show more

 • Promoted

Senior Research Compliance Specialist - Research Integrity

Emory UniversityAtlanta, GA, United States
Full-time

Discover Your Career at Emory University.Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the futu... Show more