Associate Director, Regulatory Affairs CMC and Devices
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary:
As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.
You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.
Key Responsibilities:
• Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.
• Technical Authoring: 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.
• Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.
• Device & Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.
• Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.
• Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.
• Other duties as assigned.
Ideal Candidate:
• Bachelor’s degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).
• Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.
• Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.
• Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.
• Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.
• Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.
• Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.
• Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).
What We Offer:
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• 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 deve
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Role Summary:
As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.
You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.
Key Responsibilities:
• Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.
• Technical Authoring: 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.
• Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.
• Device & Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.
• Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.
• Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.
• Other duties as assigned.
Ideal Candidate:
• Bachelor’s degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).
• Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.
• Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.
• Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.
• Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.
• Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.
• Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.
• Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).
What We Offer:
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• 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 deve
Apply tot his job
Apply To this Job