Regulatory and Site Activation Specialist

• Support regulatory submissions, site activation, and maintenance for awarded projects
• Serve as the primary point of contact for sites throughout site start-up, from site identification to activation and maintenance
• Act as the country-level internal point of contact for regulatory and site activation activities
• Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents
• Review and advise on country timelines
• Communicate submission status and action plans to the Regulatory Affairs Manager and project team
• Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents
• Track regulatory documents by site and country and follow up with sites and internal team members
• Identify country- and site-level risks and generate mitigation strategies
• Advise on appropriate 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
• Provide local quality control of submission dossiers when required
• Support translation review of submission documents when needed
• Perform other assigned duties

• 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
• Fluent in local language
• Working knowledge of English
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Strong organizational, planning, management, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
• Ability to handle multiple tasks
• 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 prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality
• Familiarity with SOPs, ICH GCP, and applicable regulations

• Equal employment opportunities
• Diverse and inclusive work environment
• Supportive and collaborative teams
• Professional growth and development opportunities