Strategic SSU & Regulatory Affairs Lead

ERGOMED; Kraków; On-site; PLN 150,000 - 230,000; Full time

Job summary

Ergomed is a specialist clinical research organization focusing on rare disease and oncology trials. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities to achieve site initiation readiness, ensuring regulatory compliance and acting as a key liaison between internal teams, clients, and external stakeholders.

The role requires a graduate degree in Chemistry or Life Sciences (or nursing) and at least 2 years in pharma/CRO, with solid knowledge of ICH-GCP and

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Minimum 2 years within pharmaceutical or CRO industry or Regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency.
• Good understanding of country requirements pertaining to SSU/Regulatory delivery in multiple Europe/Americas countries.

Responsibilities

• Lead and coordinate all activities related to achieving site initiation readiness.
• Ensure regulatory compliance and serve as liaison between internal teams, clients and stakeholders.
• Deliver regulatory/SSU milestones within scope and timelines.
• Draft, review and finalize regulatory and site-related documents across countries.
• Review labels, patient information, diaries, insurance for compliance.
• Provide regulatory/SSU strategic input and develop regulatory strategy and plans.
• Identify and escalate risks to project team and support corrective actions.
• Perform other related duties as assigned.

Skills

ICH-GCP knowledge

Regulatory affairs

Education

Chemistry degree

Life Sciences degree

Nursing qualification

Job description

Ergomed is a specialist clinical research organization focusing on rare disease and oncology trials. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities to achieve site initiation readiness, ensuring regulatory compliance and acting as a key liaison between internal teams, clients, and external stakeholders.

The role requires a graduate degree in Chemistry or Life Sciences (or nursing) and at least 2 years in pharma/CRO, with solid knowledge of ICH-GCP and