Regulatory and Start Up Specialist – Fluent in Hungarian

🔥 45 minutes ago

🌐 Poland, Hungary – Remote

🇵🇱 Poland – Remote 🇭🇺 Hungary – 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 within assigned countries/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, project trackers, and regulatory intelligence tools • Prepare or 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 review and collection of essential documents • 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 • Act as subject matter expert for site-level critical-path and Site Activation data points • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach when needed • Maintain knowledge of local clinical trial laws and regulations and distribute knowledge internally • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • Support the clinical team with 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 as a Regulatory or Start Up specialist, or comparable role, in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Fluency in Hungarian • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English • Candidates must be legally authorized to work in the country of employment without employer sponsorship • A qualification in Pharmacy or work experience as a Pharmacist would be highly beneficial • 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

• Regular full-time employment • Remote work arrangement • Equal opportunity employment • Reasonable accommodation available for applicants with disabilities