Study Start Up and Regulatory Affairs Specialist

📋 Description

• Lead and coordinate activities to achieve site initiation readiness.
• Prepare, review, and QC regulatory and study start-up documentation.
• Draft, negotiate, and finalize clinical site and ancillary agreements.
• Provide regulatory/SSU strategic input and develop regulatory strategy.
• Ensure compliance with ICH-GCP and country-specific requirements.
• Review documentation like labels and patient info sheets for compliance.

🎯 Requirements

• Graduate degree in Chemistry, Life Sciences, or Nursing.
• Minimum 2 years in pharmaceutical or CRO industry.
• Good knowledge of ICH GCP and national regulations.
• Understanding of SSU/Regulatory delivery in multiple countries.

🎁 Benefits

• Collaborative international team
• Flexibility and work-life balance
• Career growth and ownership early
• Purpose-driven work in rare disease and oncology