Regulatory and Start Up Specialist

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

📋 Description

• Accountable for the timely and quality delivery of site activation readiness within the designated countries/sites, while proactively identifying and mitigating any potential risks.

• Responsible for the preparation of Clinical Trial Application Forms and the development of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local bodies, adhering to local requirements and timelines to secure all necessary authorizations/approvals for conducting the Clinical Trial in compliance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with CA/EC for study-related purposes and manage responses to the CA/EC.

• Provide regular updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.

• Maintain project plans, project trackers, and regulatory intelligence tools pertinent to assigned responsibilities while keeping Regulatory Leadership informed.

• Prepare and support the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.

• Collaborate with the assigned site CRA to ensure effective communication and manage the collection of essential documents required for site activation/IMP release.

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

• Facilitate the translation and coordination of translations for various documents.

• Ensure ongoing communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups concerning project-specific status and deliverables.

• Act as a Subject Matter Expert (SME) for the collection and maintenance of site-level critical path data points for Site Activation, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to secure timely site activation for the assigned sites in the country.

• When necessary, participate in or support the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designated department.

• May assist the feasibility group in site outreach to evaluate potential interest from investigators for a forthcoming study.

• Keep current with local clinical trial laws and regulations and share knowledge within PFM to ensure the conduct of Clinical Trials in alignment with international and local/national regulations.

• Maintain audit and inspection readiness at all times, organizing documents as per the TMF plan or study-specific plans within the relevant TMF.

• May assist the clinical team in conducting Pre-Study Site Visits.

⛳️ Requirements

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

• A qualification in Pharmacy or work experience as a Pharmacist would be highly advantageous.

• Proven experience in contracts and budgeting negotiation.

• Experience as a Regulatory or Start-Up specialist in either a CRO or pharmaceutical/biotech industry is desirable, along with relevant experience and/or demonstrated competencies.

• Excellent communication and organizational skills.

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

• Fluency in English is required.

🏝️ Benefits

• Competitive salary

• Remote work options