Specialist Study Start Up & Regulatory Affairs

📋 Description

• Responsible for completing SSU and regulatory deliverables per SSU & RA plan.
• Liaise with SSU/regulatory team, authorities, vendors, sites for planning, organizing and executing
• Manage low-complexity study start-up activities under senior guidance.
• Prepare regulatory information for submissions to national authorities and ECs/IRBs.
• Track essential documents for Study Start-Up; ensure accuracy and completeness.
• Draft, negotiate, and execute clinical site agreements and amendments per timelines.

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent.
• Experience in pharmaceutical/CRO industry.
• Strong knowledge of ICH GCP and national regulations for relevant territories.
• Good written and verbal communication; English proficiency.

🎁 Benefits