RemoteLeaf Logo
Log in Sign up

Regulatory Affairs Specialist (North America)

1 month ago
United States, Canada
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 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

Apply Now

Similar Roles

EQT

Compliance Specialist - Operations & Risk

EQT 251-1K Gas Utilities

EQT is hiring a Compliance Specialist to support its Compliance Operations & Risk team with high-volume compliance monitoring, control testing, and reporting for LNG and LPG operations.

United States Junior Compliance Manager
5 hours, 13 minutes ago
Distro

DIS-18087 Hiring Remote Regulatory Manager

Distro 11-50 Internet Software & Services

Regulatory Manager / Sr. Regulatory Manager at Marketing Review Services, supporting clients in food, dietary supplement, cosmetic, and OTC industries with labeling, claims, and compliance review.

United States Full-time Lead Compliance Manager
$130k-$170k
5 hours, 43 minutes ago
Binance

Binance Accelerator Program - Compliance/Sanctions

Binance 5K-10K Capital Markets

Binance is hiring an early-career compliance intern to support sanctions and counter-terrorist financing work within its global blockchain ecosystem.

Hong Kong Internship Entry Level Compliance Manager
Blockchain
5 hours, 58 minutes ago
FiscalNote

Policy Analyst Contractor

FiscalNote 251-1K Diversified Financial Services

FiscalNote Europe is hiring an independent Policy Analyst in Brussels to verify and translate AI-assisted EU policy monitoring into accurate client-facing insight.

Belgium Contract Junior Compliance Manager
$43k-$43k
2 days, 5 hours 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