Associate Director, Regulatory Affairs CMC and Devices

Spyre Therapeutics is a clinical-stage biotechnology company seeking an Associate Director, Regulatory Affairs CMC and Devices to support the execution of CMC and Device regulatory activities.

Requirements

• Regulatory Submissions: Plan and coordinate global regulatory submissions
• Technical Authoring: Independently author and compile Module 2 and Module 3 content
• Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies
• Device & Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products
• Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership
• Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners

Benefits

• Market competitive compensation and benefits package
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities
• Remote working environment