Senior Manager, CMC Regulatory Affairs - Remote

Overview

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

In Short

• Play a key role in executing CMC regulatory activities.
• Author, review, and coordinate CMC regulatory submissions.
• Contribute to regulatory strategies and ensure compliance.
• Lead submissions across multiple drug candidates.
• Collaborate with Technical Operations, Quality, and external partners.
• Draft and maintain high-quality CMC regulatory documents.
• Support regulatory interactions with global health authorities.
• Implement CMC regulatory strategies for clinical trials.
• Contribute to the development of efficient regulatory processes.
• Manage multiple deliverables in a fast-paced environment.

Requirements

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs.
• Experience with authoring CMC sections of regulatory filings.
• Strong knowledge of global CMC clinical regulatory requirements.
• Experience with biologics and drug-device combination products preferred.
• Excellent attention to detail and communication skills.
• Ability to manage multiple timelines effectively.
• Proficiency with regulatory document management systems.

Benefits

• Opportunity to work in a dynamic environment with a young company.
• Market competitive compensation and benefits package.
• Unlimited PTO.
• Two company-wide shutdowns each year.
• Commitment to professional development opportunities.
• Remote working environment with in-person meetings.