Regulatory and Start Up Specialist

TL;DR

Regulatory and Start Up Specialist (Clinical Research): Delivery of site activation readiness within assigned country/sites, preparation of clinical trial application forms and submission dossiers with an accent on timeliness, quality, and risk mitigation. Focus on interacting with Competent Authorities/Ethics Committees, managing essential documents collection, and ensuring compliance with ICH-GCP and local regulations.

Location: Remote, Hungary

Company

Precision for Medicine is a Clinical Research Organization enabling precision medicine through integrated clinical trial designs, operational expertise, biomarker analytics, focusing on rare diseases, oncology, and other therapeutic areas.

What you will do

• Prepare Clinical Trial Application Forms, submission dossiers, amendments, and notifications for Competent Authorities, Ethics Committees, and local bodies.
• Interact with CA/EC, handle responses, and provide regular updates to Start Up Lead, Regulatory Lead, and Project Team.
• Maintain project plans, trackers, regulatory intelligence tools, and support development of study-specific start-up plans and IMP release requirements.
• Partner with site CRA for essential documents collection, customize Patient Information Sheets and Informed Consent Forms, and facilitate translations.
• Maintain communication with key functions like Feasibility, Clinical Operations, Project Management, and Site Contracts on project status.
• Act as SME for site-level critical path data, support budget/contract negotiations, feasibility outreach, and keep updated on local clinical trial regulations.

Requirements

• Fluency in English.
• Bachelor’s degree in life sciences or related field, or Registered Nurse, or equivalent; Pharmacy qualification or Pharmacist experience highly beneficial.
• Demonstrated experience as Regulatory or Start Up specialist in CRO, pharma/biotech, or equivalent.
• Strong communication and organizational skills.
• Experience using computerized systems, spreadsheets, word processing, and email.

Nice to have

• Relevant experience in regulatory submissions, site start-up, feasibility, contract negotiations.
• Experience with milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree (MD, PhD, PharmD), RAC certification, or Masters in Regulatory Science.

Culture & Benefits

• Remote work.
• Equal Opportunity Employer.
• Audit/inspection readiness maintained at all times.