Regulatory and Start Up Specialist, Portuguese Speaker

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

📋 Description

• Ensure timely and high-quality readiness for site activation across designated countries/sites while identifying and addressing potential 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 their responses effectively.

• Provide consistent updates on submissions to Start Up/Regulatory Leads and Project Managers/Project Teams.

• Maintain project plans, trackers, and regulatory intelligence tools to support operations.

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

• Collaborate with assigned site CRAs to ensure effective communication and secure site activation.

• Review and oversee essential documents necessary for site activation and the release of IMP.

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

• Manage the coordination of document translations.

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

• Serve as a subject matter expert on critical-path-to-site-activation data points at the site level.

• Assist in the negotiation of study budgets and the execution of investigator contracts as needed.

• Support feasibility site outreach when necessary.

• Stay informed about local clinical trial regulations and share insights within Precision for Medicine.

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

• Assist clinical teams in conducting Pre-Study Site Visits.

⛳️ Requirements

• Located in Spain.

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

• A qualification in Pharmacy or relevant work experience as a Pharmacist is highly advantageous.

• Proven experience in contract and budget negotiations, alongside regulatory submissions experience.

• Fluent in English and Portuguese.

• Prior experience as a Regulatory or Start Up specialist in a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies.

• Excellent communication and organizational abilities.

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

• Preferred experience in regulatory and site start-up functions.

• Experience with milestone tracking tools/systems is preferred.

• An advanced degree in medical or life sciences, RAC certification, or a Master's in Regulatory Science is preferred.

🏝️ Benefits

• Remote work arrangement within Spain.

• Regular full-time employment status.

• Equal opportunity employer.

• Reasonable accommodations available during the application process.