Global Study Start-Up & Regulatory Affairs Lead

ERGOMED

Madrid

On-site

EUR 50,000 - 70,000

Full time

2 days ago

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Job summary

Ergomed is seeking a Regulatory Start-Up Specialist to lead and coordinate all regulatory activities ensuring site initiation readiness for multi-country trials. You will ensure compliance with ICH-GCP and country-specific requirements, manage essential documents, and support risk management and strategic input across internal and external stakeholders.

You will contribute to drafting and finalizing regulatory and site-level agreements, translating documents as needed, and maintaining timelines

Qualifications

Degree in Chemistry or Life Sciences or related field.
Experience in pharmaceutical or CRO regulatory delivery.
Good knowledge of ICH GCP and national/regional regulations.

Responsibilities

Lead and coordinate study start-up and regulatory milestones within defined scope.
Make independent decisions on regulatory processes and documentation approaches.
Handle medium-complexity regulatory environments, including multi-country requirements.
Lead start-up and regulatory activities for assigned countries or medium projects.
Draft, negotiate, finalize, and execute site and ancillary agreements within timelines.
Review labels, patient information sheets, and essential documents for compliance.
Provide regulatory/SSU strategic input and develop related plans and SOPs.
Identify and elevate risks; support corrective actions.
Perform other duties as assigned.