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Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel clinical trial designs, operational expertise, biomarker analytics, and a focus on rare diseases and oncology. We are seeking a Regulatory and Start-Up Specialist based in Spain to support our growing regulatory and site activation operations.
In this role, you will be responsible for ensuring timely and high-quality site activation readiness across assigned countries and sites, while identifying and mitigating risks. Key responsibilities include:
• Preparing Clinical Trial Application Forms and submission dossiers (initial and amendments) for submission to Competent Authorities, Ethics Committees, and other local bodies in compliance with local regulations, company SOPs, and ICH-GCP principles.
• Interacting with Competent Authorities and Ethics Committees, handling their responses, and providing regular updates to regulatory and project leadership.
• Maintaining project plans, trackers, and regulatory intelligence tools; developing study-specific start-up plans and IMP release requirements.
• Partnering with site CRAs to ensure alignment and secure site activation; reviewing and managing collection of essential documents.
• Customizing country/site-specific Patient Information Sheets and Informed Consent Forms; coordinating translations of regulatory documents.
• Maintaining communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on project status and deliverables.
• Acting as subject matter expert for site-level critical path data, including Competent Authority and Ethics Committee timelines, site contracts, and budget negotiation requirements.
• Participating in and supporting negotiation of study budgets and execution of investigator contracts under Site Contract Management direction.
• Supporting feasibility activities in site outreach and investigator engagement.
• Maintaining current knowledge of local clinical trial laws and regulations; ensuring compliance across the organization.
• Maintaining audit/inspection readiness and filing documents per TMF plans.
• May support clinical teams during Pre-Study Site Visits.
REQUIREMENTS:
Minimum Required:
• Bachelor's degree in life sciences or related field (ideally scientific or healthcare discipline), or Registered Nurse (RN) credential, or equivalent combination of education, training, and experience.
• Pharmacy qualification or work experience as a Pharmacist highly beneficial.
• Demonstrated experience in contracts and budgeting negotiation, combined with regulatory submissions experience.
• Fluency in English and Portuguese.
Other Required:
• Previous experience as a Regulatory or Start-Up Specialist in a CRO, pharmaceutical, or biotech industry, or equivalent relevant experience and demonstrated competencies.
• Strong communication and organizational skills.
• Experience with computerized information systems, electronic spreadsheets, word processing, and electronic mail.
Preferred:
• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions).
• Experience with milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or Master's in Regulatory Science.
