Regulatory and Start Up Specialist

Precision for Medicine is a global Clinical Research Organization with uniquely integrated offerings enabling precision medicine through novel clinical trial designs, operational and medical expertise, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology, across other therapeutic areas.

We are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. Key requirements include experience with regulatory submissions and contracts and budgeting negotiation experience for Spain.

Essential Functions:

• Ensure timely and high-quality delivery of site activation readiness within assigned countries/sites, mitigating risks.
• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for submission to Competent Authorities, Ethics Committees, and other local bodies, adhering to local requirements and timelines to obtain necessary authorizations.
• Interact with Competent Authorities/Ethics Committees for study purposes and handle their responses.
• Provide regular updates on CA/EC submissions to the Start Up Lead, Regulatory Lead, and Project Manager/Project Team.
• Maintain project plans, project trackers, and regulatory intelligence tools for assigned responsibilities.
• Develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partner with assigned site CRAs to ensure alignment in communication and secure site activation.
• Review and manage collection of essential documents for site activation/IMP release.
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms.
• Facilitate translation and coordinate translations for documents.
• Maintain communication with key functions (Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management) on project status and deliverables.
• Act as SME for site-level critical path data points, including Competent Authority, local IRB/Ethics Committee timelines, site contracts, budget negotiation requirements, and other reviews to secure on-time site activation.
• Participate in study budget negotiations and investigator contract execution under Site Contract Management’s direction.
• Support feasibility group in site outreach to assess investigator interest in potential studies.
• Stay updated on local clinical trial laws and regulations, distributing knowledge within Precision for Medicine to ensure compliance.
• Maintain audit/inspection readiness and file documents as per TMF plan.
• Support clinical team in performing Pre-Study Site Visits.

Ideal Candidate Requirements:

Minimum Required:

• A Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• A qualification in Pharmacy or work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience in contracts and budgeting negotiation.

Other Required:

• Previous experience working as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry or equivalent relevant experience.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Fluency in English and Spanish, fluency in Portuguese is a strong plus.

Preferred:

• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions).
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master's in Regulatory Science.