Specialist Study Start Up & Regulatory Affairs

About the role

Ergomed Group is seeking a Specialist in Study Start‑Up and Regulatory Affairs to support the planning, organization, and execution of study start‑up activities across its oncology and rare disease portfolio. The role works closely with project teams, authorities, vendors, and investigative sites to ensure timely and compliant study initiation.

Key responsibilities

• Execute study start‑up and regulatory deliverables according to the SSU/RA management plan.
• Prepare, collect, review, and track essential regulatory documents for submissions to national authorities and ECs/IRBs.
• Draft, negotiate, and finalize clinical site agreements, ancillary agreements, and amendments at country or regional level.
• Serve as the primary point of contact for sites, managing confidential disclosures and study information sharing.
• Coordinate with study teams, sponsors, clinical monitoring, and contracts to achieve site activation readiness.
• Review documentation (labels, patient information sheets, diary cards, insurance) for compliance with ICH GCP and local requirements.
• Arrange translation and review of essential documents as needed.

Required profile

• Experience managing low‑complexity study start‑up activities under senior guidance.
• Knowledge of regulatory submission processes and ICH GCP guidelines.
• Ability to investigate and resolve incomplete or inaccurate documentation.
• Strong organizational skills for tracking and reporting document status.

Required skills

• ICH GCP compliance
• Regulatory submission preparation
• Clinical site agreement drafting and negotiation
• Document translation coordination

What we offer

• Opportunity to work in a fast‑growing international CRO.
• Supportive culture valuing employee well‑being and career development.
• Exposure to oncology and rare disease clinical programs.