Regulatory Affairs Associate – Clinical Trials Submissions

Parexel

Regulatory Affairs Associate in Mexico ensuring compliance and managing submissions for clinical trials. Collaborating with teams and authorities while developing regulatory strategies.

Posted 7/23/2026full-timeRemote • 🇲🇽 MexicoJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies for clinical trials, with a strong focus on submissions to COFEPRIS and ethics committees. Proficient in utilizing the DIGIPRIS platform and ensuring compliance with Mexican regulations while managing multiple projects effectively.

Highest-signal resume keywords

Regulatory Affairs ExperienceCOFEPRIS SubmissionsDIGIPRIS Platform ProficiencyTechnical Writing SkillsKnowledge of Mexican Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy ImplementationRegulatory Dossier PreparationProject ManagementRegulatory ComplianceTechnical Response PreparationClinical Trial RegulationsRegulatory Submission ProcessRegulatory GuidanceRegulatory MonitoringComplex Dossier Preparation

Soft Skills

Effective CommunicationOrganizational SkillsAttention to DetailProactivityProblem-Solving

Tools & Technologies

DIGIPRIS Platform

Certifications & Qualifications

Bachelor's Degree in Health SciencesPostgraduate Degree in Regulatory Affairs

Industry Keywords

Clinical TrialsCOFEPRISEthics CommitteesRegulatory AffairsHealth SciencesPharmacobiologyChemistryRegulatory ComplianceMexican RegulationsRegulatory Projects

About the role

Key responsibilities & impact

Implement comprehensive regulatory strategies for clinical trials in Mexico
Prepare, review, and submit regulatory dossiers to COFEPRIS and Ethics Committees
Manage the complete regulatory submission process under the new simplification agreement
Utilize the DIGIPRIS platform for regulatory procedures and tracking
Prepare high-quality technical responses to COFEPRIS requirements
Maintain effective communication with regulatory authorities and ethics committees
Provide expert regulatory guidance to internal teams and clients
Monitor changes in Mexican regulations and assess their impact on projects
Ensure compliance with timelines and quality standards for all deliverables
Collaborate with global and local teams in the execution of clinical studies

Requirements

What you’ll need

Bachelor's degree in Health Sciences, Chemistry, Pharmacobiology, or related fields (required)
Postgraduate degree in Regulatory Affairs or related areas (desirable)
Minimum 1-2 years of experience in regulatory affairs for clinical trials in Mexico
Demonstrable experience with submissions to COFEPRIS and ethics committees
Proven track record of successfully managing multiple regulatory projects
Knowledge of Mexican regulations for clinical trials
Ability to manage multiple projects and prepare complex regulatory dossiers
Good at handling of the DIGIPRIS platform
Excellent technical writing skills for COFEPRIS responses
Proficiency in English (oral and written)
Excellent organizational skills and attention to detail
Ability to work under pressure and meet strict deadlines
Effective communication skills with diverse stakeholders
Proactivity and problem-solving capabilities.

Benefits

Comp & perks

Opportunity to work for a leading global CRO
Innovative projects with top-tier pharmaceutical clients
Collaborative and multicultural work environment
Continuous professional development and training
Competitive compensation package