Global SSU & Regulatory Lead for Rare Disease Trials

ERGOMED; England; On-site; GBP 60,000 - 90,000; Full time

Job summary

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs to coordinate site initiation readiness across assigned countries. You will provide subject matter expertise, ensure regulatory compliance and act as a liaison between internal teams, clients, and external stakeholders.

The role requires a graduate degree in life sciences, at least 2 years in pharma/CRO, and solid knowledge of ICH-GCP and country-specific SSU requirements.

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

Responsibilities

• Lead regulatory/SSU activities for assigned countries or projects.
• Prepare and review regulatory docs, submissions, and translations.
• Draft and finalize site agreements and amendments as required.
• Ensure compliance with ICH-GCP and country-specific rules

Skills

Regulatory affairs

SSU

ICH-GCP

Multi-country delivery

Education

Chemistry/Life Sciences degree

Nursing

Job description

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs to coordinate site initiation readiness across assigned countries. You will provide subject matter expertise, ensure regulatory compliance and act as a liaison between internal teams, clients, and external stakeholders.

The role requires a graduate degree in life sciences, at least 2 years in pharma/CRO, and solid knowledge of ICH-GCP and country-specific SSU requirements.