Senior Manager, Regulatory Affairs

About this role

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, and IL-17A/F as well as rational combination programs.

As Senior Manager, Regulatory Affairs, you will play a key role in supporting regulatory planning and execution, initially focused on Spyre’s global Phase 3 clinical program, with the opportunity to contribute across the organization. Reporting to the Associate Director, Regulatory Affairs, this hands-on role will support study development, global study start-up, and clinical trial application lifecycle management.

You will work closely with regulatory leadership and cross-functional project teams to establish regulatory plans, applications, processes, and define priorities. You will independently manage assigned deliverables, including submission planning and execution, document preparation and review and CRO oversight, while progressively assuming day-to-day regulatory leadership for designated studies within the overall program direction and regulatory strategy led by the Associate Director.

You will identify regulatory risks and align regulatory activities across Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, CMC, Nonclinical, and Quality. You will also provide practical regulatory input to study documents and support health authority interactions and responses. This role requires strong communication and collaboration skills to resolve complex regulatory issues, align project teams, and adapt quickly to drive work forward in a fast-moving, dynamic environment.

Key Responsibilities:

• Regulatory Strategy and Planning: Support the development and implementation of regulatory strategies for assigned studies. Create and maintain submission plans, country-level timelines, document requirements, and executive dashboards for global study start-up and ongoing study conduct.

• Document Preparation and Review: Contribute to and coordinate preparation and review of clinical and regulatory documents, including protocols, amendments, informed consent templates, investigator’s brochures, briefing documents, and country-specific submission documents. Ensure cross-document consistency and manage documents through the applicable document management system.

• Regulatory Submissions: Prepare, compile, review, and coordinate clinical trial applications and related submissions to the FDA, EMA/EU Member States, and other global health authorities in coordination with global CRO partners. This includes original INDs/CTAs, substantial amendments, annual reports, DSURs, and responses to health authority requests for information.

• CRO and Vendor Oversight: Manage regulatory activities performed by CROs and vendors within agreed study plans and timelines. Establish clear expectations, track deliverables, review country-specific submission packages for quality and completeness, drive issue resolution, and escalate significant quality, timeline, compliance, or program-level risks with impact assessments and recommended actions.

• Health Authority Activities: Support health authority interactions and meeting preparation with the Associate Director and Regulatory Affairs leadership by coordinating cross-functional input, contributing to briefing materials, managing response development, and ensuring commitments and follow-up actions are completed.

• Risk Identification: Anticipate regulatory risks and bottlenecks that could affect study timelines, propose practical mitigations, and escalate issues promptly to Regulatory Affairs leadership with clear options and recommendations.

• Regulatory Intelligence: Monitor evolving regulations, guidance, and country-specific requirements relevant to the therapeutic area and stage of development and share practical implications with the team.

• Process and Compliance: Contribute to Regulatory Affairs processes, templates, and trackers, and support audit and inspection readiness for assigned studies.

• Other duties as assigned.

Ideal Candidate:

• Minimum of Bachelor’s required; degree and 5-7+ years of experience in pharmaceutical regulatory affairs and/or related disciplines required advanced degree in a related disciplines is a plus.

• Demonstrated ability to contribute to study-level regulatory strategies, and develop submission plans, timelines, document requirements, and trackers to support global study start-up and ongoing study conduct.

• Experience managing clinical regulatory submissions in US, EU CTR and globally, including initial applications, amendments, health authority responses, multi-country study start-up, and ongoing application maintenance.

• Experience overseeing CROs and vendors to deliver compliant regulatory submissions on schedule.

• Strong knowledge of global pharmaceutical regulations and guidance, including FDA, EMA, and ICH requirements.

• Proficient in regulatory/technical writing, including authoring or contributing to clinical trial protocols and amendments, informed consent templates, investigator’s brochures, DSURs, safety reports, briefing documents, and IMPDs.

• Excellent communication, interpersonal, and collaboration skills, with a team-first approach and a track record of building trust across functions and with external partners.

• Strong organizational and project management skills, with the ability to meet deadlines, prioritize competing demands, and manage multiple submissions simultaneously.

• Proficiency with regulatory affairs software, document management systems such as Veeva RIM, and tracking tools such as Smartsheet or Excel.

• Familiarity with combination product/device (e.g., pre-filled syringe and/or auto-injector) considerations is a plus.

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What

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