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Director, Regulatory Affairs at Spyre Therapeutics - ApplyBlast

Director, Regulatory Affairs

Spyre Therapeutics

10 days ago

4.7 on Glassdoor

Remote

Full Time

Director

0 applicants

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About this role

The Director, Regulatory Affairs leads global regulatory strategies and submissions for Spyre Therapeutics' drug candidates, focusing on the IBD program. This role involves planning clinical trials, preparing regulatory dossiers, and managing interactions with health authorities like the FDA and EMA. The position requires collaboration with cross-functional teams to ensure compliance and successful product approvals.

Responsibilities

Develop and implement regulatory strategies for clinical trials and marketing applications
Prepare and submit regulatory applications and dossiers to global health authorities
Plan and lead meetings with global health authorities and develop briefing materials

Skills

About Spyre Therapeutics

spyre.com

Headquarters

Waltham, Massachusetts, United States

Company Size

11-50 employees

Founded

2023

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Spyre Therapeutics is a biotechnology company focused on engineering next‑generation therapies for inflammatory bowel disease (IBD). The company applies precision engineering and translational research to design targeted biologics and therapeutic candidates intended to improve efficacy and safety for patients with IBD. Spyre advances its programs through preclinical and clinical development in collaboration with academic and industry partners, aiming to transform treatment options and patient outcomes.