Principal Clinical Trial Regulatory Affairs - +4 years of experience in regulatory submissions in LATAM - Argentina, Mexico or Brazil Home Based

July 9

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Collaborates as Regulatory Subject Matter Expert with major functional area leads • Participates in strategic development activities • Line management responsibilities for staff members • Develops and maintains strategic relationships with customers • Ensures all project deliverables meet customer expectations • Update plans in accordance with Standard Operating Procedures • Prepare/assist and present overall submission strategy at client meetings

🎯 Requirements

• Bachelor’s Degree, Higher Degree Preferred • Subject matter expertise in current regulation frameworks • Experience in working to applicable GxPs • Strong knowledge of clinical research management processes • Previous experience in budgeting and quality management • Ability to teach/mentor team members • Ability to coach employees

🏖️ Benefits

• Passionate about developing our people • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Committed to our Total Self culture