Senior Regulatory and Start Up Specialist, Argentina

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

📋 Description

• Ensure timely and high-quality readiness for site activation at designated locations in Argentina while identifying and mitigating risks.

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, and other relevant 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, and regulatory intelligence tools to ensure compliance.

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

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

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

• Tailor country and site-specific Patient Information Sheets and Informed Consent Forms as needed.

• Coordinate the translation of submission documents to ensure clarity and compliance.

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

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

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

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

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

• Support Pre-Study Site Visits, feasibility outreach, country start-up summaries, training, mentoring, client updates, and proposal activities as required.

• Perform additional tasks as assigned by management.

⛳️ Requirements

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

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

• Professional-level proficiency in English.

• Fluency in English and, for non-English-speaking regions, the local language of the country where the role is based.

• Strong communication and organizational skills are essential.

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

• Ability to prioritize tasks effectively to meet deadlines.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory standards.

• Must exhibit excellent computer skills.

• Capacity to work independently in a fast-paced setting.

• Some travel may be necessary.

🏝️ Benefits

• Some travel may be necessary.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.