Senior Manager, Regulatory Affairs

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.

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 development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $160000 to $176000. Actual pay offered may vary depending on job related knowledge experience education and geographic location. As an equal opportunity employer Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other non-job-related characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics along with other biotech companies has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.