Strategic SSU & Regulatory Affairs Specialist

ERGOMED; England; On-site; GBP 40,000 - 60,000; Full time

Job summary

Ergomed in the United Kingdom is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities aimed at achieving site initiation readiness.

You will provide regulatory subject matter expertise, ensure ICH-GCP compliance, draft and review documents, and serve as a key liaison between internal teams, sponsors, and sites.

The role requires a graduate degree in life sciences and prior CRO/pharma regulatory experience across Europe and the Americas.

Qualifications

• Experience in pharmaceutical or CRO industry.
• Good knowledge of ICH GCP and country regulations for territories of competency.
• Experience delivering SSU/Regulatory in Europe and/or the Americas.

Responsibilities

• Lead and coordinate all activities related to achieving site initiation readiness.
• Provide regulatory subject matter expertise and ensure regulatory compliance.
• Draft, negotiate, finalize and execute regulatory and start-up documentation.
• Review labels, patient information sheets and ancillary documents for compliance.
• Coordinate translations of essential documents and liaise with internal teams and stakeholders.
• Identify and escalate regulatory risks and support CAPAs as needed.
• Contribute to regulatory strategy and SSU plans.

Skills

Regulatory affairs

ICH-GCP knowledge

Cross-country regulatory delivery

Education

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent

Job description

Ergomed in the United Kingdom is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities aimed at achieving site initiation readiness.

You will provide regulatory subject matter expertise, ensure ICH-GCP compliance, draft and review documents, and serve as a key liaison between internal teams, sponsors, and sites.

The role requires a graduate degree in life sciences and prior CRO/pharma regulatory experience across Europe and the Americas.