Regulatory Affairs Specialist (North America)

📋 Description

• Coordinate day-to-day regulatory filings and submissions.
• Conduct regulatory reviews and create training materials.
• Provide regulatory, ethics and pharmacovigilance guidance.
• Represent unit at project meetings and regulatory audits.
• Develop and maintain corporate regulatory strategies.
• Prepare regulatory submissions and summaries.

🎯 Requirements

• Undergraduate degree and 4-6 years in Clinical Research/Regulatory Affairs.
• Strong knowledge of LATAM clinical trial regulations.
• Fluency in English and Spanish (written and verbal).
• Home-based position.
• Accommodations for applicants with disabilities available on request.
• Experience responding to regulatory queries and audits.

🎁 Benefits

• Home-based work arrangement.
• Accommodations for disabilities available on request.
• Exposure to LATAM regulatory programs.