Regulatory and Start-Up Specialist

This is a fully remote position, open to applicants in Romania.

📋 Description

• Ensure prompt and high-quality site activation readiness for designated countries/sites while anticipating and addressing potential risks.

• Compile Clinical Trial Application forms and submission documentation for Competent Authorities, Ethics Committees, and other local organizations.

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

• Provide updates on submissions to Start Up and Regulatory Leads, Project Managers, and project teams.

• Keep project plans, trackers, and regulatory intelligence tools up to date.

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

• Collaborate with assigned site CRAs to ensure effective communication and facilitate site review and collection of essential documents.

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

• Organize document translations and manage translation activities.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status updates and deliverables.

• Serve as the subject matter expert for site-level critical-path data that supports site activation.

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

• Aid in feasibility activities and outreach to investigator sites when required.

• Stay informed about local clinical trial laws and regulations, sharing regulatory knowledge within Precision for Medicine.

• Ensure audit and inspection readiness while organizing documents according to TMF and study-specific plans.

• Support clinical teams during Pre-Study Site Visits.

⛳️ Requirements

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

• Proven experience as a Regulatory or Start Up Specialist, or in a similar role within a CRO, pharmaceutical, or biotechnology setting, or equivalent relevant experience and/or demonstrated skills.

• If applying from Romania, proficiency in Romanian, Hungarian, and English is required.

• Excellent communication and organizational abilities.

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

• Proficient in English.

• A qualification in Pharmacy or experience working as a Pharmacist would be advantageous.

• Preferred experience in regulatory and site start-up activities, milestone tracking tools/systems, and prioritizing workloads.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and continuing education.

• Flexible working hours and work-from-home options.

• A supportive and inclusive work environment.