---
title: 'Director, Regulatory Affairs at Spyre Therapeutics'
canonical: 'https://feeny.ai/job/director-regulatory-affairs-spyre-therapeutics-united-states-s1347dxbe7z9'
type: 'job'
last_seen: '2026-11-03'
---

# Director, Regulatory Affairs at Spyre Therapeutics

- **Company:** Spyre Therapeutics
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-10-30
- **Last confirmed live:** 2026-11-03
- **Apply:** https://job-boards.greenhouse.io/spyretherapeutics/jobs/5467058008

## Job description

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, IL-23, and IL-17A/F as well as rational combination programs.

Role Summary:

- As the Director, Regulatory Affairs, you will play a key role in managing and overseeing regulatory affairs activities and execution within our organization, initially focused on Spyre’s IBD program. You will be responsible for planning and executing regulatory strategies that enable Spyre to initiate and manage clinical trials. You will also contribute to preclinical, CMC, and clinical development plans with the goal of ensuring Spyre performs the necessary studies to gain and maintain product approval(s) that are consistent with our target product profile(s).
- You will act as the overall lead of global regulatory applications for one or more drug candidates and will lead the submission of original investigational new drug and clinical trial applications. You will lead efforts to plan and prepare for meetings with global health authorities (Type C & EOP2 meetings with FDA, EMA scientific advice, etc.) and support live discussions. You will also support the team by contributing to the development of other assets for which you are not the overall lead, and by contributing to the development of processes for the Regulatory Department.

Key Responsibilities:

- Regulatory Strategy: Develop and implement regulatory strategies that enable the company’s clinical trials and marketing applications. Stay current with evolving regulatory requirements and industry trends and advise the company on regulatory expectations.
- Regulatory Submissions: Prepare, review, and submit regulatory applications and dossiers to health authorities, such as the FDA, EMA, PMDA, and other global regulatory agencies, ensuring timely and successful approvals.
- Health Authority Meetings: Plan meeting strategy, lead the development of briefing materials, capture action items, and support the team in implementation and strategy.
- Communication: Represent the company in regulatory interactions and maintain effective communication with regulatory agencies, responding to inquiries and requests in a professional and efficient manner. Communicate regulatory agency interactions and guidance to Regulatory Affairs leadership and cross-functional teams.
- Risk Management: Identify potential regulatory risks and proactively develop strategies to mitigate them. Monitor changes in regulatory landscapes and assess their impact on the company's products.
- Regulatory Intelligence: Keep abreast of new and evolving regulations, guidelines, and best practices in the pharmaceutical industry and adapt company strategies accordingly.
- Cross-functional Collaboration: Collaborate with other departments, including Pre-clinical Research & Development, Clinical Development, Technical Operations, Legal, and Quality and Compliance to ensure regulatory considerations are integrated into the product development process.
- Budget Management: Contribute to development and management of the regulatory affairs budget for assigned projects, ensuring cost-effective use of resources while maintaining high-quality regulatory activities.

Ideal Candidate:

- Bachelor’s degree with 8-10 years of experience in pharmaceutical regulatory affairs and/or related disciplines, or an equivalent combination of relevant education, training, and experience.
- Proven track record of successfully managing complex regulatory submissions
- Proven experience managing clinical trial applications in the US and globally
- Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
- Proficient in medical and/or technical writing, including the ability to author or contribute to documents such as Module 2 and 3 summaries, DSURs, safety reports, investigational brochures, clinical trial protocols, clinical trial reports, and/or IMPDs
- Excellent leadership, communication, and interpersonal skills
- Strong problem-solving and critical thinking abilities
- Ability to meet deadlines and adapt to changing priorities
- Proficiency in regulatory affairs software and document management systems.
- Experience with CMC regulatory, device (e.g., pre-filled syringe and/or auto-injector) and/or diagnostic (e.g., companion diagnostics)

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 $220,000 to $245,000. 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/.

## About Spyre Therapeutics

## Company Overview
- **One-liner**: Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation antibody therapies and rational combinations to elevate the standard of care for inflammatory bowel disease (IBD) and other immune-mediated diseases.
- **Entity Type**: Public (NASDAQ: SYRE [ir.spyre.com](https://ir.spyre.com/overview))
- **Headquarters**: Not publicly available (company operates 100% remote with frequent in-person meetings [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics))
- **Founded**: Not publicly available
- **Founders**: Not publicly available

## Core Business
- **Primary industry/industries**: Biotechnology / Biopharmaceuticals / Immunology
- **Target customers**: B2B (partners, healthcare providers, payers); primarily focused on patients with IBD (Crohn’s disease, ulcerative colitis) and other immune-mediated conditions
- **Mission or purpose statement**: “Develop potentially best-in-class therapeutics for people living with IBD” by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations [spyre.com](https://www.spyre.com/)

## Products & Services
Spyre’s pipeline consists of investigational extended half-life antibodies targeting validated mechanisms, designed for subcutaneous administration and potentially improved efficacy and convenience:
- **SPY001 (α4β7 integrin inhibitor)**: Phase 3-ready anti-integrin antibody with extended half-life; targeting gut-selective inflammation control [spyre.com](https://www.spyre.com/pipeline)
- **SPY120 (TL1A antibody)**: Phase 1/2 anti-TL1A antibody targeting fibrostenotic and inflammatory pathways in IBD [spyre.com](https://www.spyre.com/pipeline)
- **SPY130 (IL-23 antibody)**: Phase 1/2 anti-IL-23 p19 antibody targeting a validated and highly successful mechanism in IBD [spyre.com](https://www.spyre.com/pipeline)
- **SPY002 (α4β7 + TL1A) and SPY003 (α4β7 + IL-23)**: Rational combination programs designed to deliver more complete disease control and greater durability than monotherapy

## Market Standing
- **Valuation/Market Cap**: Not explicitly stated; recent public offering raised substantial capital
- **Key Metric**: **Total Funding via Public Offering**: $463.5 million gross proceeds from a public offering and full exercise of underwriters’ option, announced May 1, 2026 (upsized from $403.0M) [ir.spyre.com](https://ir.spyre.com/overview)
- **Notable Investors/Partners**: The company is publicly traded; institutional and retail investors participated in the offering. Partnership and investor details are disclosed in SEC filings.
- **Growth Signals**:
  - Announced positive **SPY001 Part A Induction Results** on April 14, 2026, demonstrating proof-of-mechanism [ir.spyre.com](https://ir.spyre.com/overview)
  - Raised $463.5M in a single public offering in May 2026, signaling strong institutional confidence
  - Pipeline advancing into Phase 2 and Phase 3 programs across multiple antibody formats
  - Company is rapidly expanding its R&D and clinical capabilities

## Competitive Advantages
- **Rational Combination Strategy**: Spyre is one of the few companies pioneering concurrent targeting of α4β7 with TL1A or IL-23 in a single therapeutic program, potentially offering superior efficacy over single-target biologics
- **Extended Half-Life Antibody Engineering**: All pipeline antibodies are engineered for longer dosing intervals, which could improve patient adherence and convenience
- **100% Remote-First Model**: Operates a fully remote team with periodic in-person gatherings, allowing access to top talent across geographies without requiring relocation
- **Deeply Validated Biology**: All three primary targets (α4β7, TL1A, IL-23) are clinically validated in IBD, derisking the pipeline

## Strategic Focus
- Advance **SPY001** into Phase 3 trials for IBD
- Progress **SPY120** and **SPY130** through Phase 1/2 dose optimization and proof-of-concept studies
- Generate clinical data for the **rational combination programs (SPY002, SPY003)** to demonstrate additive/synergistic benefit
- Leverage the significant capital raise to expand clinical operations, manufacturing, and pipeline expansion

## Why Work Here
- **100% Remote-First Culture**: Spyre is fully remote with “frequent all team, in-person meetings to build relationships and problem solve” [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics)
- **Generous Time Off**: Unlimited PTO plus two one-week company-wide shutdowns each year
- **Competitive Compensation**: Market-competitive base salary, performance bonus, and equity grant opportunities
- **Comprehensive Benefits**: Health, welfare, and retirement benefits included
- **Fast-Paced Startup Environment**: Opportunities to “wear multiple hats, learn quickly, and help shape the culture of our young company”
- **Mission-Driven**: Direct impact on improving the lives of millions of IBD patients. The team is described as “collaborative and interdisciplinary” [spyre.com](https://www.spyre.com/careers)
- **Transparent and Accessible Leadership**: Company updates and financial results are shared regularly; recent events include public webcasts and presentations

## Sources
1. [spyre.com](https://www.spyre.com/)
2. [ir.spyre.com](https://ir.spyre.com/overview)
3. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/spyretherapeutics)
4. [spyre.com/careers](https://www.spyre.com/careers)
5. [spyre.com/pipeline](https://www.spyre.com/pipeline)

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