Regulatory and Start Up Specialist

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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 for assigned countries/sites and identify or 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 • Coordinate with assigned site CRAs and manage essential document collection 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 teams • Maintain site activation critical-path data, including authority and ethics timelines, contracts, and budget requirements • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach and pre-study site visits • Maintain knowledge of local clinical-trial laws and regulations and support audit/inspection readiness and TMF filing

🎯 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/competencies • Romanian, Hungarian, and English for candidates applying from Romania • Strong communication and organizational skills • Experience with computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English • Pharmacy qualification or pharmacist work experience highly beneficial • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Advanced medical/life-sciences degree, RAC certification, or Master’s in Regulatory Science preferred