Regulatory and Start Up Specialist, Fluent in Hungarian

🔥 45 minutes ago

🌐 Hungary, Slovakia – Remote

🇭🇺 Hungary – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 23%

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 Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Deliver timely, 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 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 • Prepare or support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRA and manage collection of essential documents for site activation/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 and Site Activation data points • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach and pre-study site visits when required • Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within PFM • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans

🎯 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, comparable CRO/pharmaceutical/biotech experience, or equivalent relevant experience and/or competencies • Fluency in Hungarian • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English • A 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 in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred