Regulatory and Start Up Specialist – Fluent in Hungarian

This is a fully remote position, open to applicants in Slovakia, +1 more country.

📋 Description

• Ensure prompt and high-quality readiness for site activation in designated countries/sites while identifying and mitigating potential risks.

• Prepare Clinical Trial Application forms and submission packages for Competent Authorities, Ethics Committees, and other local entities.

• Engage with Competent Authorities and Ethics Committees, managing correspondence and responses.

• Provide updates on submissions to Start Up/Regulatory Leads and Project Managers/Project Teams.

• Maintain project timelines, trackers, and regulatory intelligence tools.

• Develop or assist in creating study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

• Collaborate with site CRAs to ensure effective communication and the acquisition of site documents.

• Review and oversee the essential documents necessary for site activation and IMP release.

• Tailor country/site-specific Patient Information Sheets and Informed Consent Forms.

• Coordinate the translation of documents.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Serve as a Subject Matter Expert (SME) for site-level critical-path-to-activation data points.

• Assist with study budget negotiations and the execution of investigator contracts as needed.

• Support feasibility site outreach when required.

• Keep abreast of local clinical trial laws and regulations.

• Ensure audit/inspection readiness and organize documents within the relevant Trial Master File (TMF).

• Assist with Pre-Study Site Visits when necessary.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN) designation, or a comparable combination of education, training, and experience.

• Proven experience as a Regulatory or Start Up specialist (or a similar role) within a CRO or the pharmaceutical/biotech industry, or equivalent pertinent experience and/or demonstrated competencies.

• Proficient in Hungarian.

• Excellent communication and organizational abilities.

• Familiarity with computerized information systems, electronic spreadsheets, word processing, and email communication.

• Proficient in English.

• Legally permitted to work in the country of employment without requiring employer sponsorship.

• Pharmacy qualification or experience as a pharmacist is highly advantageous.

• Preferred background in regulatory and site start-up experience.

• Experience with milestone tracking tools/systems is preferred.

• An advanced degree, RAC certification, or a Master’s in Regulatory Science is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and support for work-life balance.

• Collaborative and innovative work environment.