Regulatory and Start Up Specialist, Portuguese Speaker

🔥 16 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 and high-quality site activation readiness for assigned countries/sites and identify and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular 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 assigned site CRA to align communication and secure site activation • Review and manage essential documents required 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 Management teams regarding project status and deliverables • Act as subject matter expert for site-level critical-path-to-site-activation data points • Support study budget negotiations and execution of investigator contracts when required • Support feasibility site outreach when required • Maintain knowledge of local clinical trial laws and regulations and share knowledge within Precision for Medicine • Maintain audit and inspection readiness and file documents in the relevant TMF • Support clinical teams performing Pre-Study Site Visits

🎯 Requirements

• Based in Spain • Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • Qualification in Pharmacy or work experience as a Pharmacist highly beneficial • Demonstrated experience in contracts and budgeting negotiation, in addition to regulatory submissions experience • Fluency in English and Portuguese • Previous experience 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 • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Remote work arrangement in Spain • Regular full-time employment • Equal opportunity employment • Reasonable accommodation available during the application process