RemoteLeaf Logo
Log in Sign up

Regulatory Affairs Specialist (North America, LATAM, EU)

3 weeks 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 43

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

Similar Roles

CertiK

Compliance Engineer Intern

CertiK

CertiK is hiring a regulatory research and compliance support role to help its Engineering team with licensing analysis, AI output review, and client deliverable preparation for Web3 security and digital asset work.

Asia Europe Internship Entry Level Compliance Manager
LLM
2 hours, 1 minute ago
Binance

Case Analyst (Arabic speaker)

Binance 5K-10K Capital Markets

Binance is seeking a Case Analyst to support its global compliance and law enforcement engagement work within its blockchain and digital-asset ecosystem.

Bahrain Jordan Full-time Junior Compliance Manager
Blockchain
2 hours, 1 minute ago
Capgemini

FBS Regulatory Affairs (Remote)

Capgemini 100K+ Internet Software & Services

FBS (Farmer Business Services), part of Farmers operations, is hiring a Regulatory Affairs support professional to handle routine data collection, reporting, and administrative work for complaint response and regulatory tracking.

Mexico Brazil Full-time Entry Level Compliance Manager Operations Specialist
2 hours, 1 minute ago
Asset Living

Affordable Housing Compliance Specialist

Asset Living 1K-5K Real Estate

Asset Living is hiring an Affordable Housing Compliance Specialist to review resident applications and files for eligibility and regulatory compliance across affordable housing properties.

United States Full-time Mid Level Compliance Manager
$60k-$60k
2 hours, 16 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers