Regulatory Affairs Specialist

What you'll do

The work is modelled on the part of regulatory affairs most people in the field find hardest: answering an agency's information request. You author evaluation tasks inspired by real agency questions and sponsor response threads, then decide whether a drafted response actually meets regulatory expectations.

The distinction the ad keeps returning to is between a response that is substantively adequate and one that is merely polished. You check whether conclusions are supported by the data, whether commitments are scoped so the sponsor can keep them, and whether claims stay consistent across a whole document set rather than contradicting each other between modules. Every judgment needs a written rationale anchored in the applicable guideline.

Collaboration is asynchronous, and you will be expected to explain regulatory reasoning in writing and, occasionally, verbally.

Who fits

• Five or more years of direct regulatory affairs experience at a sponsor, CRO or consultancy, with responsibility for clinical submissions
• A record of drafting or leading responses to health authority information requests, ideally on live filings
• Working knowledge of ICH guidelines, CTD/eCTD structure and the practical expectations of at least one major agency (FDA, EMA, MHRA, PMDA or Health Canada)
• The habit of reading clinical and safety documents for unsupported statements and likely reviewer objections
• A degree in life sciences, pharmacy, medicine or a related field; RAC certification helps
• Multi-region experience, a former reviewer or assessor background, or exposure to AI-assisted regulatory tools all count in your favour

No prior AI experience is required.

What it pays

$50–80/hour, micro1's published band. The ad does not say what places you within it, and no compensation structure (hourly versus per task) is stated. For a senior regulatory professional the top of the band is below typical consulting day rates, so this makes most sense as flexible side work rather than a replacement for a retainer.

Worth knowing

Good:

• Thirty openings, flagged as high demand
• The tasks mirror genuine regulatory work, so your judgment transfers directly
• Former agency reviewers are explicitly welcome, which is unusual
• No AI background needed

Less good:

• Five years of submissions responsibility is a real floor; general QA or medical writing experience alone is unlikely to be enough
• No weekly hours, project length or pay structure published
• The customer is not named
• Contractor engagement: no benefits, your own tax to manage

About this listing

Posted by micro1 on its referral jobs board and read on 24 September 2026. The $50–80/hour band, the thirty openings and the qualifications above are from micro1's own text. Location is listed as remote with no country restriction. The ad does not state payment schedule or hours.

See micro1.