Regulatory and Start Up Specialist – Fluent in Hungarian

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

📋 Description

• Ensure timely and high-quality readiness for site activation within designated countries/sites while proactively identifying and addressing potential risks.

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

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

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

• Maintain project plans, trackers, and tools for regulatory intelligence.

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

• Collaborate with the assigned site CRA to ensure effective communication and secure the review and collection of essential documents from the site.

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

• Oversee the translation of documents.

• Facilitate communication with teams in Feasibility, Clinical Operations, Project Management, Regulatory Affairs, and Site Contracts.

• Serve as the subject matter expert on critical-path and Site Activation data points at the site level.

• Assist in study budget negotiations and the execution of investigator contracts as necessary.

• Provide support for feasibility site outreach when required.

• Stay informed about local clinical trial regulations and share knowledge within the organization.

• Ensure audit/inspection readiness and organize documents in accordance with TMF and study-specific plans.

• Assist the clinical team with Pre-Study Site Visits when necessary.

⛳️ Requirements

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

• Proven experience in a Regulatory or Start Up specialist role, or a similar position within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Proficiency in Hungarian.

• Excellent communication and organizational abilities.

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

• Proficiency in English.

• Candidates must be authorized to work in the employment country without the need for employer sponsorship.

• A qualification in Pharmacy or experience as a Pharmacist is highly advantageous.

• Relevant regulatory and site start-up experience is preferred.

• Experience with milestone tracking tools/systems is preferred.

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

🏝️ Benefits

• Regular full-time employment.

• Remote work arrangement.

• Equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.