Study Start Up and Regulatory Affairs Specialist (2 years plus experience)

Kraków, Lesser Poland Voivodeship, pl💼 Full-time🗓 2026-09-22 → 2026-09-26

Core

Leads study start-up and regulatory activities to achieve site initiation readiness for clinical trials in rare disease and oncology.

Role type

Study Start Up and Regulatory Affairs Specialist

Builds

Clinical trial sites and regulatory submissions for early-phase biotech partners

Domain

Clinical research / Rare disease and oncology

Deliverable

client delivery

Required skills

ICH-GCP knowledge, multi-country regulatory compliance, clinical site agreement negotiation, regulatory documentation preparation, risk identification, translation coordination

Preferred skills

Experience in Europe and/or Americas, complex technical/scientific/legal documentation review

Technologies

None stated

Responsibilities

Coordinate site initiation readiness, lead regulatory activities for assigned countries, prepare and review regulatory documentation, draft and execute clinical site agreements, review patient-facing materials for compliance, escalate project risks, develop regulatory and SSU strategies

Seniority

Mid-level, hands-on IC

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About Ergomed

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.