Hungarian Regulatory Start-Up Specialist (Remote)

Precision for Medicine; Polska; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist fluent in Hungarian to join our growing team. This remote Poland position involves preparing submissions, coordinating with authorities, and maintaining regulatory plans to enable timely site activation.

The ideal candidate has a life sciences degree, Hungarian fluency, English fluency, and prior regulatory/start-up experience in CRO or pharma. Strong communication and organization are essential in a global setting.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Fluency in English and Hungarian.
• Experience as Regulatory or Start Up specialist in CRO or pharma.
• Knowledge of local regulatory processes and ICH-GCP.

Responsibilities

• Prepare Clinical Trial Application forms and submission dossiers to authorities and ethics committees.
• Coordinate CA/EC submissions and respond to inquiries from authorities.
• Provide updates on submissions to Start Up/Regulatory leads and project teams.
• Maintain regulatory trackers, plans, and intelligence tools.
• Support start-up plans, IMP release requirements, and essential document review.
• Collaborate with site CRAs to ensure alignment and site activation readiness.
• Collect and manage essential documents for site activation and IMP release.
• Customize patient information sheets and consent forms per country/site.
• Coordinate translations of documents and liaise with cross-functional teams.
• Monitor timelines for CA/EC/IRB submissions and site activation milestones.
• Assist in budget negotiation and investigator contract execution as needed.
• Keep updated on local clinical trial laws and maintain TMF readiness.

Skills

Hungarian fluency

Strong communication

Organizational skills

Regulatory/start-up experience

Education

Bachelor's in life sciences

RN or Pharmacy qualification (beneficial)

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist fluent in Hungarian to join our growing team. This remote Poland position involves preparing submissions, coordinating with authorities, and maintaining regulatory plans to enable timely site activation.

The ideal candidate has a life sciences degree, Hungarian fluency, English fluency, and prior regulatory/start-up experience in CRO or pharma. Strong communication and organization are essential in a global setting.