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Regulatory Affairs Specialist (North America, LATAM, EU)

1 month, 1 week ago
Brazil, United States, Canada, Poland
Full-time
Mid Level
Compliance Manager
Legal
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 32

Description

  • Coordinate the day-to-day delivery of regulatory services and process regulatory filings, submissions, and revisions for projects, vendors, and clinical sites.
  • Manage clinical trial applications to Competent Authorities, Ethics Committees, and Regulatory Agencies.
  • Conduct or assist with regulatory and safety reviews and create regulatory tools, training materials, and stakeholder resources.
  • Provide regulatory, ethics, and pharmacovigilance guidance and support to project stakeholders as the corporate subject matter specialist.
  • Represent the unit in project meetings, regulatory reviews, audits, and communications with clients and regulatory authorities.
  • Respond to regulatory queries on behalf of clients when appropriate.
  • Identify changes in regulatory requirements and industry best practices and help implement corporate regulatory strategies.
  • Work with safety and quality assurance experts to maintain compliance with evolving regulatory initiatives.
  • Assist with regulatory submissions, support summaries, and registration requests.
  • Maintain, archive, and manage project and clinical site files and ensure stakeholders are informed and trained on applicable requirements.

Requirements

  • Undergraduate degree required.
  • 4-6 years of relevant experience in Clinical Research or Regulatory Affairs.
  • Strong knowledge of LATAM clinical trial regulations.
  • Fluency in English and Spanish, both written and verbal, required.
  • Experience supporting regulatory submissions and clinical trial applications is required.
  • Ability to work from a home-based location.
  • Experience preparing regulatory-related tools, educational materials, or stakeholder guidance is preferred.
  • Experience collaborating with safety, quality assurance, sponsors, researchers, and regulatory authorities is preferred.

Benefits

  • Home-based working arrangement.
  • Accommodations for job applicants with disabilities available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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