Senior Regulatory and Start Up Specialist, Mexico

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Ensure timely and high-quality readiness for site activation at designated Mexico locations while mitigating risks.

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, and other local entities.

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

• Provide updates on submissions to Start Up/Regulatory Leads and Project Managers/teams.

• Maintain project plans, trackers, and regulatory intelligence tools.

• Assist with study-specific start-up plans, IMP release requirements, and essential document review criteria.

• Collaborate with site CRAs to coordinate communication and enhance site cooperation.

• Prepare, review, and oversee essential documents for site activation and IMP release.

• Tailor country/site-specific Patient Information Sheets and Informed Consent Forms.

• Organize document translations as needed.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Serve as a subject matter expert for site activation critical-path data, timelines, contracts, and budget requirements.

• Assist with negotiations on study budgets and execution of investigator contracts.

• Stay updated on local clinical trial laws and regulations and share regulatory knowledge accordingly.

• Ensure audit/inspection readiness and organize documents within the relevant TMF.

• Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring, and client updates as necessary.

• Carry out additional tasks assigned by management.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse (RN) designation, or a comparable combination of education, training, and experience.

• A minimum of 3.5 years as a Regulatory or Site Start-Up specialist within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Professional-level proficiency in English.

• Fluency in English and the local language of the country in which the position is located.

• Experience with computerized information systems, electronic spreadsheets, word processing, and email communications.

• Understanding of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.

• Strong communication, organizational, presentation, and interpersonal skills.

• Capability to prioritize tasks and meet deadlines effectively.

• Ability to work independently in a fast-paced environment.

• Proficient computer skills.

• Occasional travel may be necessary.

• Must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Flexible working arrangements and a supportive work environment.