Talent.com
Micro1
Remote Regulatory Affairs SpecialistMicro1 • Bogota, New Jersey, US
No longer accepting applications
Remote Regulatory Affairs Specialist

Remote Regulatory Affairs Specialist

Micro1 • Bogota, New Jersey, US
30+ days ago
Salary
$50.00 hourly
Job type
  • Full-time
  • Remote
Job description

Regulatory Affairs Specialist

$50 - $70/hourpay

Required Skills

regulatory affairs

clinical documentation review

ich guidelines

ctd/ectd structure

written communication

critical thinking

regulatory submissions

health authority interactions

attention to detail

remote 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 • Bogota, New Jersey, US

Similar jobs

Regulatory Product Specialist

AdyenNew York, NY, United States
Full-time

Our fast-paced North America Regulatory Team is looking for a Regulatory Product Specialist to provide oversight and assistance to Adyen's established and future product and service offerings.As a ... Show more

 • Promoted

Associate, U.S. Regulatory Reporting

RBCJersey City, NJ, United States
Full-time

Associate Director, Regulatory Reporting and Strategy.Finance team is seeking an Associate Director to join the regulatory reporting and strategy function for the U.Intermediate Holding Company (IH... Show more

 • Promoted

Associate Director, Regulatory Affairs

KMR Search GroupNew York, NY, United States
Full-time

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Company's quality, preclinica... Show more

 • Promoted

Regulatory Reporting Analyst

AqmetricsNew York, NY, United States
Full-time

Are you looking for a new challenge to grow an exciting SaaS company as a Regulatory Reporting Analyst? Then continue reading.Step 1: After you apply, our HR Manager may reach out to you for an int... Show more

 • Promoted

Director, Regulatory Affairs

Eikon TherapeuticsJersey City, NJ, United States
Full-time

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lif... Show more

 • Promoted

Regulatory Remediation Consultants

Veterans Sourcing GroupNew York, NY, United States
Full-time

Regulatory Remediation Consultant.The ideal candidate has Senior VP director experience in audit within credit market liquidity or model risk to look at forbearance framework.Ideal profiles we are ... Show more

 • Promoted

Associate Principal Scientist, Global Regulatory Lead

OrganonJersey City, NJ, United States
Full-time

Associate Principal Scientist, Global Regulatory Lead.Associate Principal Scientist, Global Regulatory Lead reporting to the Executive Director, Fertility Lead will be responsible for the developme... Show more

 • Promoted

Associate, US Regulatory Services

Royal Bank of CanadaJersey City, NJ, United States
Full-time

US Regulatory Services ManagerUS Regulatory Services is responsible for ensuring timely, accurate, and complete reporting to various exchanges, self-regulatory organizations and the SEC.The individ... Show more

 • Promoted

Senior Advisor: Market Regulation & Regulatory Service Agreement (RSA)

FINRANew York, NY, United States
Full-time

Senior Advisor: Market Regulation and Regulatory Service Agreement (RSA).The Senior Advisor: Market Regulation and Regulatory Service Agreement (RSA), serves as a strategic regulatory advisor and s... Show more

 • Promoted

Director of Regulatory Affairs

Merkle ScienceNew York, NY, United States
Full-time

Merkle Science provides blockchain transaction monitoring and intelligence solutions for web3 companies, digital asset service providers, financial institutions, law enforcement and government agen... Show more

 • Promoted

Regulatory Manager - Cardiology

Columbia UniversityNew York, NY, United States
Full-time

Regulatory Manager - Cardiology.The Regulatory Manager provides operational and strategic oversight of regulatory compliance and quality assurance activities across assigned clinical research portf... Show more

 • Promoted

Regulatory Associate

Cedent Life TalentNew York, NY, United States
Full-time

We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team.In this role, you will play a vital part in supporting the development and submission of regulatory documen... Show more

 • Promoted

1940 Act Regulatory Administration Manager

U.S. BankNew York, NY, United States
Full-time

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

 • Promoted

Senior Director, Regulatory Affairs

Clinical DynamixJersey City, NJ, United States
Full-time

Senior Director, Regulatory Affairs - Northern NJ (Hybrid).Client is seeking a capable, insightful, experienced Senior Director, Regulatory Affairs.The Senior Director, Regulatory Affairs is respon... Show more

 • Promoted

Affiliate Services Licensing Specialist, Regulatory Affairs (NORAM)

StripeNew York City, NY, United States
Full-time

Affiliate Services Licensing Specialist, Regulatory Affairs (NORAM)Stripe is a financial infrastructure platform for businesses.Millions of companies - from the world's largest enterprises to the m... Show more

 • Promoted

Senior Regulatory Affairs Specialist

Careers Integrated Resources IncJersey City, NJ, United States
Full-time

Senior Regulatory Affairs Specialist.This will person will be a Regulatory liaison between product development and the regulatory agencies.This position will be responsible for regulatory submissio... Show more

 • Promoted

Regulatory Reporting Associate

Axelon Services CorporationJersey City, NJ, United States
Full-time

Pay Rate: $45 per hour Location: Jersey City, NJ.Prepare and review regulatory reports in compliance with SEC & CFTC financial regulations and internal company policies.Ensure accurate and timely s... Show more

 • Promoted

Ascend Wellness Holdings: Regulatory Administration Specialist

Viridian StaffingNew York, NY, United States
Permanent

This position is for Ascend Wellness Holdings.Please apply directly to Ascend Wellness Holdings using the following instructions:.The Regulatory Administration Specialist will be responsible for wo... Show more

 • Promoted

AVP Regulatory Reporting Analyst

eTeamJersey City, NJ, United States
Full-time

AVP Regulatory Reporting Analyst.Prepare and review regulatory reports in compliance with SEC & CFTC financial regulations and internal company policies.Ensure accurate and timely submission of all... Show more

 • Promoted

Regulatory Reporting Change Management Associate

BizTek PeopleNew York, NY, United States
Full-time

Regulatory Reporting Change Management Associate.BizTek People is in search of an experienced Regulatory Reporting Change Management Associate for our client in NYC! Pay Range: $65-70/hr Duration: ... Show more