Job Description

The Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related
to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory
compliance, and serves as a key liaison between internal teams, clients, and external stakeholders

- 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.
- Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
- 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 and within the projected delivery timelines
- 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 escalate risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions
- Performs other work-related duties as assigned.

📌 Specialist/Snr Specialist Study Start Up and Regulatory Affairs (Roma)
🏢 Ergomed
📍 Roma