Global Study Start-Up & Regulatory Lead

Ergomed Group; Guildford; On-site; GBP 45,000 - 60,000; Full time

Job summary

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

The role provides subject matter expertise in regulatory compliance and serves as a key liaison between internal teams, clients, and external stakeholders, with responsibility for multi-country delivery and timely, compliant documentation.

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Previous experience 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 countries within Europe and/or the Americas.

Responsibilities

• Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
• Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
• Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
• Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations.
• Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.
• Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
• Arrange for and/or review translation of essential documents as required.
• Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents.
• Promptly identify and escalation risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions.
• Performs other work-related duties as assigned.

Skills

Regulatory affairs

SSU understanding

Cross-country coordination

ICH-GCP knowledge

Education

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent

Job description

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

The role provides subject matter expertise in regulatory compliance and serves as a key liaison between internal teams, clients, and external stakeholders, with responsibility for multi-country delivery and timely, compliant documentation.