Director, Regulatory Affairs — Remote, Equity & Unlimited PTO

Spyre Therapeutics, Inc.; United States; Hybrid; USD 220,000 - 245,000; Full time

Benefits offered by this job

Unlimited PTO

Company-wide shutdowns

Remote work with in-person meetings

Professional development

Competitive compensation and benefits

Job summary

Spyre Therapeutics, Inc. is a clinical-stage biotechnology company advancing next‑generation immunology therapies to deliver more complete disease control, greater durability, and a simpler treatment experience for patients.

We are seeking a Director, Regulatory Affairs to lead global regulatory strategy, manage submissions to the FDA, EMA and other authorities, plan Agency meetings, and drive cross‑functional collaboration to achieve timely approvals.

Qualifications

• Bachelor’s degree with 8–10 years of experience in pharmaceutical regulatory affairs or related disciplines.
• Proven track record of successfully managing complex regulatory submissions.
• Experience managing clinical trial applications in the US and globally.
• Strong knowledge of FDA, EMA and ICH requirements.
• Proficient in medical/technical writing (Module 2/3, DSURs, safety reports, CT protocols/reports).

Responsibilities

• Develop and implement regulatory strategies to enable clinical trials and marketing applications.
• Prepare, review, and submit regulatory dossiers to FDA, EMA, PMDA, and other agencies.
• Plan and lead health authority meetings and briefing materials.
• Represent regulatory affairs in cross-functional discussions and drive timely responses to inquiries.
• Identify regulatory risks and develop mitigation strategies.
• Monitor evolving regulations and advise on impact to products.
• Collaborate with Pre-clinical, Clinical, Quality, Legal and Ops to integrate regulatory considerations.
• Contribute to regulatory budget planning and resource management.

Skills

Leadership

Communication

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in regulatory affairs

Tools

Regulatory software

Job description

Spyre Therapeutics, Inc. is a clinical-stage biotechnology company advancing next‑generation immunology therapies to deliver more complete disease control, greater durability, and a simpler treatment experience for patients.

We are seeking a Director, Regulatory Affairs to lead global regulatory strategy, manage submissions to the FDA, EMA and other authorities, plan Agency meetings, and drive cross‑functional collaboration to achieve timely approvals.