Senior Regulatory and Start Up Specialist, Mexico

Precision For Medicine

. Deliver timely, high-quality site activation readiness for assigned Mexico sites and mitigate risks .

Posted 10/26/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws and regulations. Proficient in managing essential documents, project plans, and communication across multidisciplinary teams.

Highest-signal resume keywords

Regulatory SubmissionsSite ActivationGood Clinical Practice/ICH GuidelinesProject ManagementProfessional-Level English Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Application PreparationDocument ManagementRegulatory Intelligence ToolsEssential Document ReviewBudget NegotiationSite CollaborationFeasibility OutreachAudit/Inspection ReadinessPatient Information Sheet CustomizationInformed Consent Form Management

Soft Skills

Excellent CommunicationOrganizational SkillsPresentation SkillsInterpersonal SkillsAbility to Prioritize Workload

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic Mail

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryClinical Trial LawsRegulatory Requirements

About the role

Key responsibilities & impact

Deliver timely, high-quality site activation readiness for assigned Mexico sites and mitigate risks
Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees and other local bodies
Interact with Competent Authorities and Ethics Committees and handle responses
Provide submission updates to Start Up/Regulatory Leads and Project Managers/teams
Maintain project plans, trackers and regulatory intelligence tools
Support study-specific start-up plans, IMP release requirements and essential document review criteria
Partner with site CRAs to align communication and secure site collaboration
Prepare, review and manage essential documents for site activation and IMP release
Customize country/site-specific Patient Information Sheets and Informed Consent Forms
Coordinate document translations
Communicate with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts teams
Act as subject matter expert for site activation critical-path data, timelines, contracts and budget requirements
Support study budget negotiations and investigator contract execution
Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge
Maintain audit/inspection readiness and file documents in the relevant TMF
Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring and client updates as required
Perform other duties assigned by management

Requirements

What you’ll need

Bachelors’ degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
3.5 years or more as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
Professional-level English proficiency
Fluency in English and the local language of the country where the position is based
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
Excellent communication, organizational, presentation and interpersonal skills
Ability to prioritize workload and meet deadlines
Ability to work independently in a fast-paced environment
Excellent computer skills
Occasional travel may be required
Must be legally authorized to work in the country of employment without employer sponsorship