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 in assigned countries/sites while identifying and addressing potential risks.

• Prepare Clinical Trial Application forms and submission documents for Competent Authorities, Ethics Committees, and other local regulatory bodies.

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

• Provide consistent updates on submissions to Start Up and Regulatory Leads, as well as the Project Manager/Project Team.

• Maintain project plans, tracking tools, and regulatory intelligence resources.

• Assist in preparing study-specific start-up plans, requirements for Investigational Medicinal Product (IMP) release, and criteria for essential document review.

• Collaborate with the assigned site Clinical Research Associate (CRA) to ensure alignment in communication and facilitate site activation.

• Oversee and manage the collection of essential documents necessary for site activation and IMP release.

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

• Coordinate translation activities and facilitate document translations as needed.

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

• Serve as a subject matter expert for site-level critical-path data that supports site activation.

• Participate in or support negotiations related to study budgets and the execution of investigator contracts.

• Assist with feasibility activities and site outreach when necessary.

• Keep abreast of local clinical trial laws and regulations, disseminating knowledge within Precision for Medicine.

• Ensure audit and inspection readiness by organizing documents in accordance with TMF and study-specific plans.

• Support clinical teams during Pre-Study Site Visits as required.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN) designation, 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, along with regulatory submission experience.

• Proficiency in both English and Portuguese.

• Previous experience as a Regulatory or Start Up specialist in a Contract Research Organization (CRO) or the pharmaceutical/biotech sector, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational abilities.

• Familiarity with computerized information systems, including electronic spreadsheets, word processing, and email platforms.

• Relevant regulatory and site start-up experience is preferred.

• Experience with milestone tracking tools/systems is preferred.

• Ability to prioritize tasks effectively to meet deadlines is preferred.

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

🏝️ Benefits

• Regular full-time employment.

• Opportunity for remote work from Spain.