Country Regulatory Specialist, Clinical Research

📋 Description

• Manage country-level regulatory and ethics submission activities from study start-up through
• Prepare and submit applications to regulatory authorities, central and local ethics committees, and
• Act as the primary country-level regulatory contact for health authorities and ethics committees
• Provide regulatory expertise during business development, study feasibility, and site selection
• Forecast submission and approval timelines, track milestones, analyze delays, develop mitigation
• Monitor changes in local regulatory requirements and guidelines, maintain accurate regulatory

🎯 Requirements

• A bachelor's degree in a relevant field is preferred, or an equivalent combination of education and
• At least 3–4 years of experience in clinical research, preferably in regulatory affairs or clinical
• Solid understanding of clinical trial processes across Phases I–IV, including ICH Good Clinical
• Experience with country-specific clinical trial submission procedures and applicable quality
• Strong knowledge of regulatory authority and ethics committee processes, submission requirements
• Excellent organizational, analytical, and problem-solving skills, with the ability to manage

🎁 Benefits

• Remote flexibility: Work remotely from Brazil in a full-time position.
• Career development: Access opportunities for professional growth, career progression, and ongoing
• Training and development: Benefit from technical training, therapeutic-area education, and
• Supportive management: Collaborate with engaged leaders and experienced professionals in a
• Recognition and rewards: Access peer recognition initiatives and a total rewards program.
• Global collaboration: Work with international, cross-functional teams and gain exposure to diverse