Regulatory Affairs Specialist (North America)

1 week, 2 days ago
Full-time
Mid Level
Legal
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

Description

  • Coordinate the daily delivery of regulatory services and processes across projects, third-party vendors, and clinical sites.
  • Compile regulatory filings, submissions, and revisions for clinical trial applications and related projects.
  • Conduct or assist with regulatory and safety reviews and maintain awareness of current clinical research regulations and best practices.
  • Develop regulatory tools, educational materials, and stakeholder resources to support project teams and compliance activities.
  • Provide regulatory, ethics, and pharmacovigilance guidance to project stakeholders as a subject matter specialist.
  • Represent the unit in project meetings, regulatory reviews, audits, and communications with clients, regulators, and ethics/government representatives.
  • Respond to regulatory queries on behalf of clients when appropriate.
  • Identify changes in regulatory requirements and recommend, implement, and maintain corporate regulatory strategies.
  • Work with safety and quality assurance experts to meet compliance requirements for evolving regulatory initiatives.
  • Support project and site documentation, including development, maintenance, revision, archiving, and destruction of files in line with regulatory requirements.

Requirements

  • Undergraduate degree is required.
  • 4-6 years of relevant experience in Clinical Research or Regulatory Affairs is required.
  • Strong knowledge of LATAM clinical trial regulations is required.
  • Fluency in English and Spanish, both written and verbal, is required.
  • Experience coaching peers or contributing to staff performance reviews is preferred.
  • Experience participating in specialized conferences or meetings to expand regulatory knowledge is preferred.
  • Ability to work from a home-based location is required.
  • Knowledge of corporate, industry, and regulatory standards and guidelines is required.

Benefits

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

Interested in this position?

Apply directly on the company website

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