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 managing 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 to address responses effectively.

• Provide submission updates to Start Up/Regulatory Leads and project teams regularly.

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

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

• Collaborate with site CRAs to ensure effective communication and foster site cooperation.

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

• Tailor patient information sheets and informed consent forms to be country/site-specific.

• Oversee the coordination of document translations.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding project status and deliverables.

• Serve as a subject matter expert on critical-path data, timelines, contracts, budgets, and reviews for site activation.

• Assist in study budget negotiations and the execution of investigator contracts when necessary.

• Stay informed about local clinical trial laws and regulations, sharing regulatory knowledge internally.

• Ensure audit/inspection readiness and properly 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.

• Undertake additional responsibilities as assigned by management.

⛳️ Requirements

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

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

• Proficient in professional-level English.

• Bilingual in English and the local language of the country where the position is based.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and electronic mail.

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

• Excellent skills in communication, organization, presentation, interpersonal relations, and computer usage.

• Capability to prioritize workload, meet deadlines, work independently in a dynamic environment, and interact effectively with project teams.

• Occasional travel may be necessary.

• Candidates must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Opportunity for remote work in Mexico.

• Regular full-time employment status.

• Occasional travel may be required.