Senior Manager/Associate Director, Regulatory Sciences

📋 Description

• Collaborate with CMC teams to design drug substance/product control strategies across lifecycle.
• Author and review drug substance and drug product sections for IND/CTA/NDA/MAA submissions.
• Prepare responses to health authority queries on quality.
• Maintain quality risk assessments per ICH M7, ICH Q3D, and nitrosamines.
• Advise development teams on starting materials, specifications, and manufacturing processes.
• Identify regulatory issues with potential cross project impact.

🎯 Requirements

• PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
• Experience in CMC development and regulatory authoring preferred.
• Background in drug product or analytical development is a plus.
• Familiarity with FDA/EMA/ICH guidelines for INDs/NDAs/MAAs.
• Understanding of cGMP and regulatory requirements for drug substance/product manufacturing.
• Knowledge of analytical method development/validation and stability requirements.

🎁 Benefits

• 100% employer-paid medical, dental, and vision premiums for you and dependents.
• 401(k) with employer match.
• Employee Stock Purchase Program (ESPP).
• Hybrid work model with flexibility.
• Flexible PTO and company holidays.
• Pre-tax commuter benefits.