Senior Regulatory Submissions Lead

Job Summary

Leading regulatory strategy and submissions for biotech and pharma companies, the full-time Senior Regulatory Submissions Lead will execute regulatory plans, manage submission documentation, and ensure compliance while working remotely.

Key responsibilities

• Lead and execute regulatory strategy and submissions across multiple countries throughout the study lifecycle
• Act as the primary regulatory lead for sponsors and project teams, ensuring alignment on timelines and deliverables
• Own submission documentation quality by preparing and reviewing core regulatory submission documents

Required qualifications

• University degree in pharmacy, medicine, or related natural sciences preferred
• 8-10 years of experience, including at least 6 years in a regulatory submissions role
• Experience managing submissions for complex trials across different phases globally
• Proficient in the CTIS system and knowledgeable in ICH/GCP and FDA/EU regulations
• Strong organizational and time-management skills with a customer service-focused approach