Remote Regulatory & Start-Up Specialist (Poland)

Precision Medicine Group, LLC.; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist to drive site activation readiness in Poland and surrounding regions. You will prepare CTAs, submit dossiers to authorities, and coordinate with ethics committees while ensuring compliance with ICH-GCP and local regulations.

The ideal candidate holds a life sciences degree with regulatory/start-up experience in CRO or pharma, English fluency, and Hungarian language ability to support Hungarian sites; TMF and budgeting

Qualifications

• Bachelor’s degree in life sciences or nursing; PharmD/RN beneficial
• Pharmacist qualification/experience would be highly beneficial
• Regulatory or Start Up specialist experience in CRO or pharma
• Fluency in Hungarian to support Hungarian sites and English fluency

Responsibilities

• Ensure site activation readiness for assigned country and timelines.
• Prepare CTAs and submission dossiers for authorities/EC per local requirements.
• Interact with CA/EC and provide responses as needed.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Develop start-up plans and document review criteria.
• Coordinate with site CRA to align communications and activation.
• Review and collect essential site activation documents.
• Coordinate translations of patient information sheet and ICF.
• Maintain communication with cross-functional teams on deliverables.
• Assist with study budgets and investigator contracts as required.
• Support feasibility efforts for site outreach.
• Stay updated on local clinical trial laws and ensure compliance.
• Maintain audit/inspection readiness and TMF filing.
• Support Pre-Study Site Visits when required.

Skills

Regulatory Start-Up

Hungarian language

English fluency

Communication skills

Organizational skills

Education

Bachelor’s degree in life sciences or nursing

Pharmacist qualification/experience

Advanced degree in medical/life sciences or RAC

RN qualification

Tools

Milestone tracking tools

Regulatory submission portals

TMF documentation systems

MS Word/Excel/Email

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to drive site activation readiness in Poland and surrounding regions. You will prepare CTAs, submit dossiers to authorities, and coordinate with ethics committees while ensuring compliance with ICH-GCP and local regulations.

The ideal candidate holds a life sciences degree with regulatory/start-up experience in CRO or pharma, English fluency, and Hungarian language ability to support Hungarian sites; TMF and budgeting