Lead study start-up and regulatory activities for assigned countries or projects.
Prepare, review, and QC regulatory and study start-up documentation.
Draft and negotiate clinical site and ancillary agreements.
Review labels, patient information sheets, and diary cards for compliance.
Provide regulatory/SSU strategic input and develop regulatory strategy.
Identify and escalate risks; support corrective/preventive actions.

🎯 Requirements

Graduate degree in Chemistry, Life Sciences, Nursing or equivalent.
Experience in pharmaceutical/CRO industry or regulatory body.
Good knowledge of ICH GCP and national regulations.
Understanding of SSU/Regulatory requirements in Europe and/or Americas.

🎁 Benefits

Collaborative international team.
Flexibility and work-life balance.
Opportunity to take ownership early.

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