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 within designated countries/sites while identifying and mitigating potential risks.

• Drafting Clinical Trial Application Forms and creating submission dossiers (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC), and other relevant local entities in accordance with local regulations and deadlines to secure all necessary authorizations/approvals for conducting Clinical Trials in compliance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engaging with CA/EC for study-related purposes and managing their responses.

• 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 necessary.

• Maintaining project plans, project trackers, and regulatory intelligence tools relevant to assigned duties while keeping Regulatory Leadership informed.

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

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

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

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

• Overseeing and coordinating the translation of documents required for submissions.

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

• Acting as a Subject Matter Expert (SME) for collecting and maintaining site-level critical path data points crucial to Site Activation, including Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to ensure timely site activation for the assigned sites in the country.

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

• Keeping abreast of local clinical trial laws and regulations, and sharing this knowledge within Precision for Medicine to ensure compliance with both international and local/national regulations during Clinical Trials.

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

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

• May engage with the feasibility group in site outreach to evaluate potential interest from investigators for forthcoming studies.

• May aid in developing country-specific Start-up summaries and process flows that outline timelines, risks, and success factors.

• May assist in creating 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 interact with clients to provide updates on activation readiness status, request documents or perform document review, and participate in proposal activities, including slide development and client presentations as required.

• 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.

• At least 3.5 years of experience as a Regulatory or Start-Up specialist in either a CRO or the 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 email is required.

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

• Ability to prioritize workload effectively to meet deadlines.

🏝️ Benefits

• Health insurance

• 401(k)

• Flexible work arrangements

• Professional development