Regulatory Affairs Specialist – North America

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Alimentiv

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Healthcare Insurance • Science • Pharmaceuticals

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. • Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies. • Research, review and reporting on applicable global regulations and requirements. • Develop stakeholder tools, process/document regulatory risk assessments. • Provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. • Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. • May be required to coach peers and/or provide input for staff performance reviews.

🎯 Requirements

• Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs. • The successful candidate will possess strong knowledge of LATAM clinical trial regulations. • Fluency in English and Spanish (written and verbal) required.

🏖️ Benefits

• Home-based • *Accommodations for job applicants with disabilities are available upon request.