Senior Manager, CMC Regulatory Affairs

Company Name

Spyre Therapeutics

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.

Role Summary

As the Senior Manager, Regulatory Affairs (CMC), you will play a key role in executing CMC regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.

You will lead submissions across multiple drug candidates and work closely with Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.

Key Responsibilities

• Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement.
• Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information.
• Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
• Other duties as assigned.

Ideal Candidate

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience.
• Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
• Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred.
• Excellent attention to detail, technical writing, organizational, and communication skills.
• Ability to manage multiple deliverables and timelines in a fast-paced environment.
• Proficiency with regulatory document management systems.

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 year.
• 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 $170,000 to $190,000. 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/.