Senior Specialist Study Start‑Up & Regulatory Affairs

About the role

Ergomed is seeking a Senior Specialist to lead study start‑up and regulatory affairs activities for complex rare‑disease and oncology trials. You will ensure sites are ready for initiation, maintain regulatory compliance, and act as a key liaison between internal teams, clients, and external partners.

Key responsibilities

• Lead and coordinate all activities required for site initiation readiness.
• Deliver study start‑up and regulatory milestones on time and to quality standards.
• Make independent decisions on regulatory processes and documentation approaches.
• Manage medium‑complexity, multi‑country regulatory environments.
• Prepare, review, and quality‑control regulatory and start‑up documents, including submissions, essential documents, and translations.
• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments in line with country regulations.
• Review labels, patient information sheets, diary cards, insurance documents, and other materials for ICH‑GCP and country‑specific compliance.
• Contribute to the preparation and review of complex technical, scientific, and legal documentation.

Required profile

• Several years of experience in clinical study start‑up and regulatory affairs, preferably in rare‑disease or oncology trials.
• Strong knowledge of ICH‑GCP guidelines and country‑specific regulatory requirements.
• Ability to work independently, make decisions, and manage multiple projects simultaneously.
• Excellent communication and negotiation skills with internal and external stakeholders.

Required skills

• ICH‑GCP compliance
• Regulatory submission preparation
• Clinical site agreement drafting and negotiation

What we offer

• Opportunity to work on high‑impact, complex clinical trials.
• Collaborative international team with a focus on work‑life balance.
• Professional growth within a fast‑growing CRO.