Regulatory Affairs Specialist – North America

Alimentiv

Regulatory Affairs Specialist responsible for managing clinical trial applications and delivering Global Regulatory Affairs support services. Requires expertise in LATAM clinical trial regulations and fluency in English and Spanish.

Posted 7/13/2026full-timeRemote • 🇨🇦 CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global Regulatory Affairs with a focus on LATAM clinical trial regulations, ensuring compliance with corporate and regulatory standards. Capable of managing clinical trial applications and delivering high-quality support services while collaborating with stakeholders.

Highest-signal resume keywords

Global Regulatory AffairsClinical Trial ManagementLATAM Clinical Trial RegulationsBilingual in English and SpanishRegulatory Risk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRegulatory AffairsRegulatory ComplianceStakeholder EngagementProcess DevelopmentRisk AssessmentReportingQuality AssuranceDocument ManagementPerformance Review Input

Soft Skills

CoachingCollaborationCommunicationProblem-SolvingInterpersonal Skills

Industry Keywords

Competent AuthoritiesEthics CommitteesRegulatory AgenciesGlobal RegulationsService Delivery Processes

About the role

Key responsibilities & impact

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.
Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies.
Research, review and reporting on applicable global regulations and requirements.
Develop stakeholder tools, process/document regulatory risk assessments.
Provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities.
Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines.
May be required to coach peers and/or provide input for staff performance reviews.

Requirements

What you’ll need

Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
Fluency in English and Spanish (written and verbal) required.

Benefits

Comp & perks

Home-based
*Accommodations for job applicants with disabilities are available upon request.