Specialist, Regulatory and Site Activation

Lifelancer

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

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submissions and site activation processes, with a strong understanding of ICH GCP and local regulations. Proficient in managing documentation and communication with stakeholders to ensure compliance and timely project execution.

Highest-signal resume keywords

Regulatory SubmissionsSite ActivationICH GCP KnowledgeClinical Research ExperienceMicrosoft Office Proficiency

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Document TrackingSite IdentificationPatient Information Sheet CustomizationInformed Consent Form ReviewQuality Control of Submission DossiersRegulatory Intelligence Database MaintenanceCountry Regulatory Strategy DevelopmentRisk Identification and MitigationSubmission Status CommunicationDocument Review and Critique

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsAbility to Handle Multiple TasksRelationship DevelopmentAdaptability in Fast-Paced Environments

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointContemporary Digital Systems

Industry Keywords

Clinical ResearchPharmaceutical IndustryCRORegulatory AffairsSOP Compliance

About the role

Key responsibilities & impact

Support regulatory submissions, site activation, and maintenance for awarded projects
Plan, initiate, and track documents required for regulatory submissions
Collect, review, and provide country, site, and ethics committee requirements
Support end-to-end site start-up from site identification through site activation and maintenance
Serve as the primary point of contact for sites and country-level 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 as needed
Identify country/site risks and develop mitigation strategies
Advise 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
Perform local quality control of submission dossiers when required
Act as a contact point for translation review of submission documents
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 another 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 the 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
Proficiency in Microsoft Word, Excel, and PowerPoint
Aptitude for contemporary digital systems is helpful
Ability to handle multiple tasks in a fast-paced, changing, deadline-oriented environment
Ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality
Ability to initiate and develop relationships with local investigators and key site personnel

Benefits

Comp & perks

Diverse and inclusive work environment
Supportive and cohesive teams
Accessible, hands-on leadership
Equal employment opportunities
Employee experience focused on respect and inclusion