Regulatory and Start Up Specialist

🕒 June 11

🇭🇺 Hungary – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 55%

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 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 assigned site CRA to align communications 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 • Maintain site-level critical-path data for site activation, including authority and ethics timelines, contracts and budget negotiations • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach when required • Maintain knowledge of local clinical-trial laws and regulations and distribute knowledge within Precision for Medicine • Maintain audit/inspection readiness and file documents according to TMF or study-specific plans • 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 • Qualification in Pharmacy/work experience as a Pharmacist highly beneficial • 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 • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Fluency in English • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Ability to prioritize workload to meet deadlines preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred • Must be legally authorized to work in Hungary without employer sponsorship

🏖️ Benefits

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