Senior Manager, Regulatory Affairs CMC

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

As the Senior Manager, Regulatory Affairs CMC), you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones. This is a high-impact, high-ownership role for someone who thrives in a fast-moving biotech environment.

You will be expected to lead from the front—writing, project-managing, problem-solving, and delivering—not just coordinating. This role requires technical CMC expertise, strong communication skills, and the ability to manage multiple priorities.

Key Responsibilities:

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines.

• Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.).

• Own CMC regulatory deliverables end-to-end with minimal oversight.

• Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness.

• Identify risks early and lead teams to resolution to keep programs on track.

• Translate complex technical data into clear and concise narratives.

• Lead preparation of CMC-related responses to HA questions.

• Act as a connector and leader in discussions, not a passive participant.

• Manage multiple programs, while prioritizing effectively.

• Other duties as assigned.

Ideal Candidate:

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).

• Experience as the primary CMC regulatory lead for clinical stage programs (EU CTR and ROW experience is a plus).

• Hands-on authoring experience for IND and IMPD submissions and amendments, including direct responsibility for authoring CMC sections.

• Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.

• Proven experience preparing responses to CMC health authority questions during clinical development.

• Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, and ICH.

• Strong attention to detail, organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.

• Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.

• Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).

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 $150,000 to $176,000. 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/.