Regulatory & Start-Up Specialist — Remote (Poland)

Precision Medicine Group; Polska; Hybrid; PLN 140,000 - 210,000; Full time

Job summary

Precision Medicine Group in Poland is seeking a Regulatory and Start Up Specialist fluent in Hungarian to support Hungarian sites. The role focuses on timely activation and regulatory submissions within local requirements.

You will prepare CTAs, liaise with authorities and ethics committees, maintain documentation, and collaborate with cross-functional teams to ensure compliant start-up activities across assigned countries.

Qualifications

• Bachelor’s degree in life sciences or RN/Pharmacist qualification.
• Regulatory or Start Up experience in CRO/pharma.
• Fluency in Hungarian and English; strong communication skills.

Responsibilities

• Deliver site activation readiness within assigned country/sites on time.
• Prepare Clinical Trial Applications and submissions to authorities.
• Coordinate with CA/EC and update project teams on submissions.
• Maintain regulatory trackers and start-up plans.

Skills

Hungarian fluency

Regulatory Start-Up experience

English fluency

Communication skills

Organizational skills

Education

Bachelor's degree life sciences

RN / Pharmacist qualification

Regulatory science (RAC) degree

Job description

Precision Medicine Group in Poland is seeking a Regulatory and Start Up Specialist fluent in Hungarian to support Hungarian sites. The role focuses on timely activation and regulatory submissions within local requirements.

You will prepare CTAs, liaise with authorities and ethics committees, maintain documentation, and collaborate with cross-functional teams to ensure compliant start-up activities across assigned countries.