Senior Regulatory and Start Up Specialist (Brazil)

📋 Description

• Delivery of site activation readiness within assigned country/sites
• Prepare Clinical Trial Applications and submission dossiers for CA/EC
• Interact with CA/EC and handle responses
• Provide updates to Start Up Lead/Regulatory Lead and Project Team
• Maintain project plans, trackers, and regulatory tools
• Ensure compliance with local and international regulations

🎯 Requirements

• Bachelors’ degree in life sciences or RN or equivalent
• 3.5+ years as Regulatory or Site Start Up specialist
• English proficiency (professional level)
• Excellent communication and organizational skills
• Experience with computerized systems and MS Office
• Fluency in English and local language of country when applicable

🎁 Benefits

• Remote work options
• Equal Opportunity Employer
• Supportive regulatory team and cross-functional collaboration