Medicine moves forward here. Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities relatedto achieving site initiation readiness. Leads study start-up and regulatory activities for assigned countries or projects of mediumcomplexity, ensuring delivery in line with timelines, quality standards, and regulatoryrequirements.
Leads preparation, review, and quality control of regulatory and study start-updocumentation (including submissions, essential documents, and translations) to ensurecompleteness, 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 withproject requirements and country regulations and within the projected delivery timelinesReview all relevant documentation e.g. labels, patient information sheets,



diary cards,insurance etc, to ensure compliance with ICH GCP & country specific requirements.
Develop theregulatory strategy and the SSU Plan, joint operating procedures and core documentsPromptly identify and elevate risk/potential risk to the project team which may jeopardisedeliverables; Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experiencePrevious experience within pharmaceutical or CRO industry orRegulatory bodyGood knowledge of ICH GCP and national regulations for territories of competencyGood understanding of specific country requirementspertaining to SSU/Regulatory delivery in multiple countrieswithin Europe and/or the Americas
You'lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
Quality:we hold ourselves to the standard patients deserve.

📌 Study Start Up and Regulatory Affairs Specialist (España)
🏢 Ergomed
📍 España