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Regulatory Affairs Specialist (LATAM)

1 month ago
Brazil
Full-time
Mid Level
Compliance Manager
Operations
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 processes for projects, third-party vendors, and clinical sites.
  • Manage clinical trial applications and regulatory filings, submissions, and revisions to Competent Authorities, Ethics Committees, and Regulatory Agencies.
  • Conduct or assist with regulatory and safety reviews and maintain awareness of current clinical research regulatory requirements and best practices.
  • Create regulatory-related tools, stakeholder materials, and educational or training resources.
  • Provide regulatory, ethics, and pharmacovigilance guidance and support to project stakeholders as the subject matter specialist.
  • Represent the unit in project meetings, regulatory reviews, audits, and discussions with clients and regulatory authorities.
  • Identify changes in regulatory requirements and help recommend, implement, and maintain corporate regulatory strategies.
  • Respond to registration requests and work with project teams to determine applicable regulatory requirements.
  • Support the preparation of regulatory submissions and related summaries.
  • Maintain project and clinical site files and ensure documents are developed, revised, archived, or destroyed according to requirements.

Requirements

  • Undergraduate degree is 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, is required.
  • Ability to support clinical trial applications and regulatory submissions across multiple stakeholders and authorities.
  • Experience communicating regulatory changes to project leaders in a timely manner.
  • Ability to coach peers or contribute to staff performance reviews may be required.
  • Experience working with safety, quality assurance, or other subject matter experts is preferred.
  • Participation in specialized conferences or meetings to maintain regulatory knowledge may be expected.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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