Regulatory and Site Activation Specialist

Worldwide Clinical Trials

. Support regulatory submissions, site activation, and maintenance for awarded projects .

Posted 9/24/2026full-timeRemote • MexicoJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and site activation within clinical research, with a strong understanding of ICH GCP and local regulations. Proficient in managing timelines, communication, and quality control of regulatory documents while fostering relationships with site personnel.

Highest-signal resume keywords

Regulatory SubmissionsSite ActivationICH GCP KnowledgeClinical Research ExperienceMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document ReviewPatient Information Sheet CustomizationInformed Consent Form PreparationRisk Identification and MitigationRegulatory Intelligence Database Maintenance

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsAbility to Handle Multiple TasksAdaptability

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Clinical ResearchPharmaceutical IndustryCROCountry RegulationsSOP Familiarity

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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