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 in assigned countries/sites while mitigating risks.

• Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local organizations.

• Engage with authorities and ethics committees, addressing their inquiries and handling responses.

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

• Maintain project plans, trackers, regulatory intelligence tools, and data related to site activation.

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

• Collaborate with Clinical Research Associates to ensure effective communication and foster site cooperation.

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

• Tailor patient information sheets and informed consent forms to be country/site-specific.

• Oversee the translation of documents as necessary.

• Foster communication with feasibility, clinical operations, project management, regulatory, and site contracts teams.

• Assist with negotiations regarding site contracts and budgets when needed.

• Keep up-to-date with local clinical trial laws and regulations, sharing this knowledge internally.

• Ensure readiness for audits/inspections and organize documents within the relevant TMF.

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

⛳️ 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 in a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Professional-level proficiency in English.

• Fluency in both English and the local language of Argentina.

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

• Exceptional communication and organizational skills.

• Ability to prioritize tasks effectively to meet deadlines.

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

• Strong computer, presentation, interpersonal, and organizational skills.

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

• Occasional travel may be required.

🏝️ Benefits

• Comprehensive health and wellness benefits package.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to support work-life balance.