Regulatory Strategy Lead

The Regulatory Strategy Lead provides senior regulatory and integrated project leadership for global drug development projects, with deep hands-on expertise in US and EU regulatory strategy and delivery. The role acts as both Regulatory Lead and Project Lead, with direct accountability for authoring and delivering key regulatory submissions and leading cross-functional development activities.

Requirements

• Master’s degree in Life Sciences or a related discipline
• Minimum of 8 years of relevant experience in regulatory strategy and delivery
• Demonstrated experience leading and authoring major regulatory deliverables
• Strong client-facing skills
• Advanced written and verbal communication skills
• Demonstrated judgment, resilience, and flexibility in ambiguous or high-pressure environments

Benefits

• health insurance
• 401k Matching
• Tuition Reimbursement
• Relocation Assistance