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 assigned countries/sites while mitigating risks.

• Prepare clinical trial application forms and submission dossiers 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 study leads and project teams.

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

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

• Collaborate with site CRAs to ensure effective communication and site collaboration.

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

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

• Coordinate translations for submission documents.

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

• 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.

• Keep abreast of local clinical trial laws and regulations, sharing regulatory knowledge internally.

• Ensure audit and inspection readiness by filing documents in the appropriate TMF.

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

• Perform additional duties 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 English communication skills, both verbal and written.

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

• Strong communication and organizational skills.

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

• Ability to prioritize work and meet deadlines effectively.

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

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

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

• Excellent computer proficiency.

• Outstanding written and verbal communication, presentation, and interpersonal skills.

• A flexible attitude towards work assignments and a willingness to learn.

• Occasional travel may be necessary.

🏝️ Benefits

• Occasional travel may be required.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.