Regulatory Affairs Specialist

$50–80/hrrate as listed

micro1 is contracting regulatory affairs specialists to write and grade evaluation tasks modeled on health authority information requests and sponsor response threads. You judge whether drafted responses are substantively adequate under ICH and agency expectations — not merely well-formatted — and document your reasoning in writing.

Summary, eligibility guidance and screening preparation are prepared by Sidequest from the platform's posting. Check the source listing before applying.

What the work involves

Most of your time goes to two activities. First, authoring evaluation items drawn from realistic scenarios: an FDA information request on a Module 2.7.4 safety summary, an EMA major objection on benefit-risk framing, a PMDA query about bridging data. Second, reviewing model-drafted responses and clinical documentation against those scenarios — deciding whether conclusions are actually substantiated by the cited data, whether commitments are scoped so a sponsor could keep them, and whether the record would survive a reviewer's second read.

A recurring theme is separating substance from polish. Language models produce regulatory prose that reads fluently and cites the right guidance titles while quietly asserting things the data do not support. Your job is to catch that, and to write a rationale grounded in a specific guideline, section, or precedent rather than "this feels thin." You'll also assess consistency across document sets — flagging where a claim in a clinical overview conflicts with the underlying summary, or where two responses in the same thread contradict each other.

What the platform screens for

Hands-on ownership of clinical submissions or health authority correspondence, not adjacent exposure. Expect follow-ups on specific filings you worked, your role in them, and the reasoning behind decisions you made.
Working fluency in the ICH framework and CTD/eCTD structure — where content lives, and why it lives there.
Practical knowledge of at least one major agency's expectations (FDA, EMA, MHRA, PMDA, Health Canada), including how that agency's queries typically read.
Written reasoning that is concise, defensible, and traceable to a source. Screens usually include a short written exercise or a live probe where you critique a flawed passage.

Logistics

Fully remote, contractor engagement, asynchronous. Observed pay for this role sits at $50–70/hr, varying with experience and specialization; rates are as reported and not guaranteed. Most contributors work 10–20 hours per week on their own schedule, with occasional synchronous calibration calls. No prior AI or machine learning experience is expected — the training is on the task format, not on your domain.

What they look for

regulatory affairs
clinical documentation review
ich guidelines
ctd/ectd structure
written communication
critical thinking
regulatory submissions
health authority interactions
attention to detail
remote collaboration

Before you apply

Would you pass this screen?

Drawn from what this listing actually requires. Answered in your browser — nothing is sent to us, and we do not store your answers.

Do you have 5 or more years of direct regulatory affairs experience in a sponsor company, CRO, or consultancy, with documented responsibility for clinical submissions?
Regulatory affairs experience · required
Have you drafted or led responses to health authority information requests (e.g., EMA, FDA, MHRA, PMDA, or Health Canada) as part of an ongoing regulatory filing?
Health authority submission experience · required
Do you have working knowledge of the ICH framework and CTD (Common Technical Document) or eCTD structure?
ICH and CTD knowledge · preferred
Do you hold a bachelor's degree or higher in life sciences, pharmacy, medicine, or a directly related field?
Life sciences degree · preferred
Do you hold or have you previously held a Regulatory Affairs Certification (RAC)?
Regulatory affairs certification · preferred

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Included with this listing

Interview prep — 12 questions

Matched to what this platform's screening actually measures. Answer each out loud in 60–90 seconds: claim → concrete example → implication.

What it tests: Whether you have hands-on experience authoring or leading regulatory submissions under real agency pressure, and whether you can articulate the regulatory reasoning that shaped your approach.
A strong answer: Name a concrete submission, the specific deficiency or question posed, your role in shaping the response (not just reviewing it), and the result—acceptance, approval with conditions, or a specific lesson learned. Show how regulatory guidance or agency expectations informed your strategy.
Where people lose it: Describing a response you reviewed or a project you supported tangentially, rather than one you authored or led. Vague timelines or missing the actual agency outcome, which suggests the memory is fuzzy or the role was minor.