Regulatory and Start Up Specialist

🔥 13 hours ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely, high-quality site activation readiness for assigned country/sites and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, trackers, and regulatory intelligence tools • Support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with site CRA to align communication and secure site activation • Review and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams • Maintain site-level critical path data for regulatory timelines, contracts, budgets, and required reviews • Support study budget negotiations and execution of investigator contracts • Support feasibility site outreach • Maintain knowledge of local clinical trial laws and regulations and share knowledge within PFM • Maintain audit/inspection readiness and file documents in the relevant TMF • Support Pre-Study Site Visits when required

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience • Demonstrated experience in contracts and budgeting negotiation • Previous experience working as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Fluency in English and Spanish • Qualification in Pharmacy or work experience as a Pharmacist highly beneficial • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Advanced degree, RAC certification, or Masters in Regulatory Science preferred