Hungarian Regulatory & Start-Up Specialist (Remote)

Precision Medicine Group; Warszawa; Remote; PLN 120,000 - 180,000; Full time

Job summary

Precision Medicine Group is a Clinical Research Organization seeking a Regulatory and Start Up Specialist fluent in Hungarian to join our growing team. This remote role in Poland involves ensuring timely site activation, preparing regulatory submissions, and coordinating with authorities, ethics committees, and internal teams.

The ideal candidate has a life sciences degree or RN, regulatory/start-up experience, and fluent Hungarian and English.

Qualifications

• Bachelor’s degree in life sciences or related field, or RN or equivalent combination of education, training, and experience.
• A qualification in Pharmacy/ pharmacist experience is beneficial.
• Regulatory or Start Up experience in CRO/pharma/biotech with relevant competencies.
• Fluency in Hungarian required to support Hungarian sites.

Responsibilities

• Deliver site activation readiness in the assigned country/sites with timeliness and quality.
• Prepare Clinical Trial Applications and submission dossiers for authorities and ethics committees.
• Interact with CA/EC and provide responses to submissions.
• Maintain regulatory trackers, plans, and intelligence tooling; update leadership and project teams.

Skills

Hungarian fluent

Regulatory knowledge

Project coordination

Communication skills

Education

Bachelor in life sciences

RN or equivalent

Pharmacist qualification

Tools

Regulatory systems

TMF systems

Job description

Precision Medicine Group is a Clinical Research Organization seeking a Regulatory and Start Up Specialist fluent in Hungarian to join our growing team. This remote role in Poland involves ensuring timely site activation, preparing regulatory submissions, and coordinating with authorities, ethics committees, and internal teams.

The ideal candidate has a life sciences degree or RN, regulatory/start-up experience, and fluent Hungarian and English.