Senior Regulatory and Start Up Specialist, Mexico

Precision Medicine Group

. 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. Proficient in managing essential documents, project plans, and communication with regulatory bodies and project teams.

Highest-signal resume keywords

Regulatory SubmissionsSite Activation ProcessesGood Clinical Practice/ICH GuidelinesProject ManagementClinical Trial Application Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Application PreparationRegulatory SubmissionsEssential Document ManagementProject PlanningBudget NegotiationKnowledge of Local Clinical Trial LawsSite Activation ReadinessDocument Translation CoordinationRegulatory Intelligence ToolsFeasibility Outreach

Soft Skills

Excellent CommunicationOrganizational SkillsInterpersonal SkillsPresentation SkillsAbility to Prioritize Workload

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord Processing SoftwareElectronic Mail

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryEthics CommitteesCompetent AuthoritiesAudit/Inspection ReadinessSite ContractsInvestigator Contract Execution

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 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 regarding status and deliverables
Act as subject matter expert for site activation critical-path data, timelines, contracts, budgets, and reviews
Support study budget negotiations and investigator contract execution when required
Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge internally
Maintain audit/inspection readiness and file documents in the relevant TMF
Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring, client updates, and proposal activities as needed
Perform other duties assigned by management

Requirements

What you’ll need

Bachelor’s 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, interpersonal, and computer skills
Ability to prioritize workload, meet deadlines, work independently in a fast-paced environment, and interact effectively with project teams
Occasional travel may be required
Candidates must be legally authorized to work in the country of employment without employer sponsorship

Benefits

Comp & perks

Remote work in Mexico
Regular full-time employment
Occasional travel may be required