Hungarian Regulatory & Start-Up Specialist — Remote Poland

Precision Medicine Group

Polska

Hybrid

PLN 120,000 - 180,000

Full time

3 days ago

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Job summary

Precision Medicine Group is seeking a Regulatory and Start Up Specialist fluent in Hungarian to support Hungarian sites from a remote Poland-based role. You will drive regulatory submissions, site activation readiness, and ongoing compliance across local authorities and ethics committees.

The role requires a strong background in life sciences, regulatory or start-up experience in CRO/pharma, and fluency in Hungarian and English.

Qualifications

Bachelor’s degree in life sciences or nursing/pharmacy background.
Pharmacy qualification is highly beneficial.
Experience as Regulatory or Start Up specialist in CRO or pharma.
Fluent in Hungarian and English.

Responsibilities

Deliver site activation readiness within assigned country/sites with timely, quality submissions.
Prepare CTAs and submission dossiers for authorities and ethics committees per local rules.
Interact with CA/EC and provide timely responses to submissions.
Maintain regulatory trackers, project plans, and regulatory intelligence tools.
Coordinate start-up plans, IMP release requirements, and essential document review criteria.
Collaborate with site CRAs to ensure alignment and secure site activation.
Coordinate translations of key documents and maintain country/site documentation.
Communicate status with Start Up Lead, Regulatory Lead, and project team.