Study Start Up and Regulatory Affairs Specialist

About the role

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications, partnering with small to midsize biotech companies to move promising therapies through early phase development. The Study Start Up and Regulatory Affairs Specialist leads and coordinates all activities needed to achieve site initiation readiness, provides subject matter expertise, ensures regulatory compliance and acts as a key liaison between internal teams, clients and external stakeholders. The role is based in Madrid.

Key responsibilities

• Lead study start-up and regulatory activities for assigned countries or projects of medium complexity, delivering within timelines, quality standards and regulatory requirements.
• Prepare, review and quality control regulatory and study start-up documentation, including submissions, essential documents and translations, ensuring completeness, accuracy and compliance with ICH-GCP and country-specific requirements.
• Draft, negotiate, finalize and execute clinical site agreements, ancillary agreements and amendments at country or regional level.
• Review labels, patient information sheets, diary cards and insurance documents for ICH-GCP and country compliance.
• Contribute to complex technical, scientific and legal documentation and arrange or review document translations.
• Develop the regulatory strategy, SSU plan, joint operating procedures and core documents, and provide regulatory/SSU strategic input to internal and external customers.
• Identify and escalate risks promptly, supporting corrective and preventive actions.

Required profile

• Graduate degree in Chemistry or Life Sciences, Nursing or an equivalent combination of education and experience.
• Previous experience in the pharmaceutical or CRO industry or at a regulatory body.
• Ability to handle medium-complexity regulatory environments, including multi-country requirements.

Required skills

• Good knowledge of ICH-GCP and national regulations for the territories of competency.
• Good understanding of country requirements for SSU/regulatory delivery in multiple countries within Europe and/or the Americas.