Regulatory and Start Up Specialist

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

📋 Description

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

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, and other local institutions.

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

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

• Maintain project plans, trackers, and regulatory intelligence tools to ensure accurate oversight.

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

• Collaborate with site CRAs to ensure aligned communication and facilitate site activation.

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

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

• Coordinate the translation of documents as needed.

• Communicate effectively with teams in Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts.

• Maintain critical path data at the site level for regulatory timelines, contracts, budgets, and necessary reviews.

• Assist in negotiating study budgets and executing investigator contracts.

• Support outreach for feasibility site assessments.

• Stay informed about local clinical trial laws and regulations, sharing insights within PFM.

• Ensure audit/inspection readiness and organize documents within the appropriate TMF.

• Provide support for Pre-Study Site Visits when necessary.

⛳️ Requirements

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

• Proven experience in negotiating contracts and budgets.

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

• Excellent communication and organizational abilities.

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

• Fluency in both English and Spanish is required.

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

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

• Familiarity with milestone tracking tools/systems is preferred.

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

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• A collaborative and supportive work environment.

• Flexible working arrangements.