Regulatory Specialist, Site Activation

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 10%

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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

• Support end-to-end site start-up from site identification to site activation and maintenance, serving as the primary site point of contact • Act as the internal country-level primary point of contact for regulatory and site activation activities • Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents to comply with ICH GCP and country requirements • Review and advise on country timelines for assigned studies • 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, follow up as needed, and report to the Regulatory Affairs Manager • Identify country/site-level risks and generate mitigation strategies • Advise the Regulatory Affairs Manager and project team on country regulatory strategies • Maintain 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 before dispatch when required • Act as a contact point for translation review of submission documents when required • Perform other duties as assigned

🎯 Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science • Minimum two year 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 • Strong organizational and management skills • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills • 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, changing environment • Ability to handle multiple tasks • Proficiency in Microsoft Word, Excel, and PowerPoint • Aptitude for contemporary digital systems is helpful

🏖️ Benefits

• Equal employment opportunities • Diverse and inclusive work environment • Collaboration and creativity-focused workplace • Supportive teams and accessible leaders • Opportunities for professionals from all backgrounds and experiences to succeed