Associate Director, Regulatory Affairs CMC and Devices

The Associate Director, Regulatory Affairs CMC and Devices will play a key role in executing CMC and potentially Device regulatory activities within Spyre Therapeutics. The role will involve authoring, reviewing, and coordinating CMC and Device regulatory submissions to enable the company to initiate and advance clinical trials. The Associate Director will contribute to regulatory strategies, ensure compliance with evolving regulatory requirements, and support interactions with global health authorities.

Requirements

• Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports
• Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports
• Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies
• Contribute to regulatory strategy and documentation for drug-device combination products
• Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities
• Remote working environment with frequent in-person meetings to address complex problems and build relationships