Senior Regulatory and Start Up Specialist, Brazil

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

📋 Description

• Ensure timely and high-quality readiness for site activation in designated countries/sites 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, managing responses effectively.

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

• Maintain project plans, trackers, regulatory intelligence tools, and updates for regulatory leadership.

• Support study-specific startup strategies, IMP release requirements, and criteria for essential document reviews.

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

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

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

• Coordinate translations for submission documents.

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

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

• Assist with study budget negotiations and the execution of investigator contracts as needed.

• Stay informed about local clinical trial laws and regulations and share regulatory knowledge within the organization.

• Ensure audit and inspection readiness and manage document filing in the relevant TMF.

• Facilitate Pre-Study Site Visits, site feasibility outreach, country startup summaries, training sessions, and staff mentoring as required.

• Provide clients with updates on activation readiness and support proposal initiatives.

• Perform additional tasks as assigned by management.

⛳️ Requirements

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

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

• Proficiency in English at a professional level, both verbally and in writing.

• Fluent in English and the local language relevant to the position's location.

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

• Exceptional communication and organizational abilities.

• Capability to prioritize tasks and meet deadlines effectively.

• Knowledge of Good Clinical Practice, ICH Guidelines, and relevant regulatory requirements.

• Ability to interact effectively with project teams and communicate in both English and the local language.

• Capacity to work independently in a dynamic environment.

• Strong computer skills.

• Occasional travel may be necessary.

🏝️ Benefits

• Occasional travel may be necessary.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.