Regulatory and Start Up Specialist

🕒 August 11

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 30%

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 study leads and 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 CRAs and manage essential document collection for site activation and IMP release • Customize Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with feasibility, clinical operations, project management, regulatory, and site contracts teams • Maintain site activation critical-path data and regulatory timelines • Support study budget negotiations and investigator contract execution • Support feasibility site outreach and pre-study site visits • Maintain knowledge of local clinical trial laws and regulations • Maintain audit and inspection readiness and file documents according to TMF 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 demonstrated competencies • If applying from Romania, speak Romanian, Hungarian and English • 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