Regulatory Affairs Specialist

Alimentiv

Global Regulatory Affairs support role managing clinical trial applications and delivering regulatory affairs services. Collaborating across functional units to maintain compliance with global regulations.

Posted 6/29/2026full-timeRemote • 🇦🇺 AustraliaMid-LevelSeniorWebsite

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 report on applicable global regulations and requirements.
Develop stakeholder tools and 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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical ResearchRegulatory ComplianceRegulatory ReportingStakeholder EngagementProcess Development

Soft Skills

CoachingCollaborationCommunication