Senior Regulatory and Start Up Specialist, Mexico

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

📋 Description

• Accountable for ensuring timely and quality delivery of site activation readiness across the designated country/sites while proactively identifying and mitigating any risks.

• Development of Clinical Trial Application Forms and the preparation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committees (EC), and other relevant local entities in compliance with local regulations and required timelines to secure all necessary authorizations/approvals for conducting the Clinical Trial according to international and local/national regulations, company SOPs, and ICH-GCP principles.

• Liaison with CA/EC for study-related purposes and managing responses to the CA/EC.

• Providing consistent updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team as relevant.

• Maintaining project plans, project trackers, and regulatory intelligence tools pertinent to assigned responsibilities and keeping Regulatory Leadership informed.

• Assisting in the development of study-specific start-up plans, IMP release requirements, and criteria for reviewing essential documents.

• Collaborating with the assigned site CRA to ensure effective communication and foster site cooperation.

• Preparing, reviewing, and overseeing the collection of essential documents required for site activation/IMP release.

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

• Responsible for facilitating the translation and coordination of translations for documents needed for submission.

• Maintaining communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups regarding project-specific status and deliverables.

• Acting as a Subject Matter Expert (SME) for the collection and maintenance of site-level critical path data points related to Site Activation, which includes, but is not limited to, Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to ensure timely site activation for the assigned locations in the country.

• When necessary, participating in or supporting the negotiation of study budgets and the execution of investigator contracts, under the guidance of the Site Contract Management department or designated department.

• Keeping abreast of local clinical trial laws and regulations, and helping disseminate this knowledge within Precision for Medicine to ensure the execution of Clinical Trials in compliance with international and local/national regulations.

• Ensuring audit/inspection readiness at all times and filing documents according to the TMF plan or study-specific plans within the relevant TMF.

• May assist the clinical team with Pre-Study Site Visits.

• May participate in or support the feasibility team in outreach to gauge potential investigator interest in a forthcoming study.

• May aid in the creation of country-specific Country Start-up summaries and process flows, detailing timelines, risks, and success factors.

• May assist in the development of training sessions to enhance Country Start-up knowledge and serve as a Subject Matter Expert for inquiries.

• May mentor staff on local study start-up regulations, submissions, and internal procedures.

• May engage with clients to provide updates on activation readiness, request documents or document reviews, and participate in proposal activities, including slide development and client presentations as necessary.

• Performs additional duties as assigned by management.

⛳️ Requirements

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

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

• Proficient verbal and written communication skills in English (Professional level).

• Exceptional communication and organizational skills are essential.

• Experience with computerized information systems, electronic spreadsheets, word processing, and electronic mail is required.

• Fluency in English and, for non-English speaking countries, proficiency in the local language of the country where the position is based.

• Capability to prioritize workload effectively to meet deadlines.

🏝️ Benefits

• Competitive salary

• Remote work options