Lead regulatory compliance for clinical trials as a manager. Provide expert guidance on submissions and ensure adherence to regulations throughout the clinical development lifecycle.
This role involves coordinating and reviewing regulatory documents for authorities and ethics committees. You will work closely with project teams, keeping them informed and compliant with current regulations. Your insight will shape regulatory strategies for recent studies, while overseeing regulatory specialists to meet submission targets.
Key Responsibilities:
• Guide regulatory activities across clinical development
• Compile and review regulatory submissions for authorities
• Participate in project meetings with external and internal stakeholders
• Maintain project plans and regulatory quality initiatives
• Provide training on ICH GCP to clients and teams
Requirements:
• Bachelor's degree in scientific or healthcare field
• 5+ years of regulatory affairs experience
• Knowledge of drug development regulatory milestones
• Experience with EU or US regulatory activities
• Strong interpersonal skills for team collaboration
Shape the future of clinical trials by ensuring regulatory excellence and compliance through comprehensive oversight and strategic input.
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Apply on Kit Job: kitjob.ca/job/2frwtu
📌 Clinical Regulatory Affairs Manager (Moncton)
🏢 Precision for Medicine
📍 Moncton
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