Remote Hungarian Regulatory & Start-Up Specialist

Precision for Medicine; Warszawa; Remote; PLN 120,000 - 200,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist fluent in Hungarian to support Hungarian sites and global trials. You will prepare CTAs and start-up dossiers, interact with authorities, and maintain project trackers to ensure timely activation of study sites.

Strong communication skills in English and Hungarian are essential, with experience in CRO or pharmaceutical settings preferred. The role is remote with focus on Poland-based operations.

Qualifications

• Bachelor’s degree in life sciences or related field (ideally healthcare).
• Nursing/Pharmacy qualification would be beneficial.
• Proven Regulatory or Start Up experience in CRO/pharma.
• Fluency in Hungarian and English required.

Responsibilities

• Prepare CTAs and submission dossiers for authorities and ethics committees.
• Interact with CA/EC and respond to inquiries.
• Maintain project plans, trackers and regulatory intelligence tools.
• Coordinate translations and site activation materials.
• Collaborate with cross-functional teams (Clinical Ops, PM, Regulatory).

Skills

Regulatory start-up experience

Regulatory submissions

Hungarian language

English fluency

Project coordination

Education

Bachelor’s degree in life sciences or healthcare

Nursing or Pharmacy qualification (beneficial)

Tools

Milestone tracking tools

Regulatory databases

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist fluent in Hungarian to support Hungarian sites and global trials. You will prepare CTAs and start-up dossiers, interact with authorities, and maintain project trackers to ensure timely activation of study sites.

Strong communication skills in English and Hungarian are essential, with experience in CRO or pharmaceutical settings preferred. The role is remote with focus on Poland-based operations.