Specialist, Regulatory & Site Activation

🕒 August 21

🌐 Argentina, Brazil – Remote

🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 28%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Serve as subject matter expert and local point of contact for regulatory submissions, site activation, and maintenance for awarded projects • Plan, initiate, and track documents required for regulatory submissions and essential document collection • Support end-to-end site start-up from site identification to site activation and maintenance • Act as internal primary point of contact at country level for regulatory and site activation activities in assigned studies • Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents to comply with ICH GCP and country-specific requirements • Review and provide advice on country timelines • Communicate submission status and action plans to the Regulatory Affairs Manager and project team • Collect, receive, and perform first review of study-specific site regulatory and essential documents • Track regulatory documents by site and/or country and follow up as needed • Identify risks and generate country/site-level mitigation strategies • Advise on appropriate country regulatory strategies • Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities • Provide updates on changing regulatory requirements and support interpretation of new regulations • Maintain the regulatory intelligence database for the assigned country • Comply with SOPs, ICH GCP, and applicable regulations • Provide local quality control of submission dossiers where required • Support translation review of submission documents where required • Perform other duties as assigned

🎯 Requirements

• Strong organizational and management skills • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills • Self-motivated learning about current regulatory processes and intelligence • Excellent written and verbal communication skills • Proactive issue identification and solution anticipation • Thorough understanding of country-level cultural norms and local healthcare systems • Ability to initiate and develop relationships with local investigators and key site personnel • Ability to adjust to a changing environment and prioritize detailed and strategic activities while maintaining delivery timelines and quality • Team-oriented work style • Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment • Ability to handle multiple tasks in a fast-paced and changing environment • Proficiency in Microsoft Word, Excel, and PowerPoint • Aptitude for contemporary digital systems is helpful • A minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science • Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related function • Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations • Multilingualism preferred; fluent in local language; working knowledge of English

🏖️ Benefits

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law