Regulatory specialists prepare and follow up study submissions to health authorities and ethics committees. Their work directly affects study start-up timelines in each country.
What they do
- · Prepare and submit initial dossiers, amendments and notifications.
- · Follow up on questions from health authorities and ethics committees.
- · Track the validity of approvals.
- · Work closely with start-up teams, the sponsor and sites.
Why a specialised profile matters
Each Latin American country has its own regulator, requirements and timelines — for example ANMAT (Argentina), ANVISA (Brazil), COFEPRIS (Mexico) and INVIMA (Colombia), along with local ethics committee processes. A general regulatory profile from other industries may not know how clinical trial submissions work.
Define the profile
- · Countries to cover.
- · Stage: start-up, maintenance or both.
- · Sponsor, CRO or site side.
- · English level for global documentation and communication.
What to assess
- · Hands-on experience with clinical trial submissions in the relevant countries.
- · How they handle and answer authority questions.
- · Organisation across multiple studies and deadlines.
ECR Talent supports regulatory affairs searches for clinical research across Latin America.
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