Senior Manager, Regulatory Affairs CMC

Regulatory Jobs; United States; Hybrid; USD 150,000 - 176,000; Full time

Benefits offered by this job

Unlimited PTO

Company-wide shutdowns

Equity grant opportunities

Remote-friendly environment

Job summary

Spyre Therapeutics is seeking a Senior Manager, Regulatory Affairs CMC to lead strategy and execution for multiple programs, from early development through clinical milestones. This role requires hands‑on authoring for IND/IMPD submissions and effective cross‑functional leadership in a fast‑moving biotech setting.

The ideal candidate will have 5+ years in CMC regulatory affairs for clinical‑stage biologics, strong technical writing, and deep knowledge of FDA/EMA/ICH guidelines.

Qualifications

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs
• 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 ability to clearly communicate complex regulatory information
• Strong knowledge of FDA, EMA, and ICH guidelines

Responsibilities

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines
• Author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability)
• Own CMC regulatory deliverables end-to-end with minimal oversight
• Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports)
• Identify risks early and lead teams to resolution to keep programs on track
• Translate complex data into clear regulatory narratives
• Prepare CMC responses to health authority questions
• Lead discussions and coordinate cross-functional teams
• Manage multiple programs with effective prioritization
• Other duties as assigned

Skills

Regulatory lead

CMC expertise

Regulatory writing

Cross-functional leadership

Project management

Attention to detail

Regulatory strategy

Education

Bachelor’s degree

Tools

Veeva RIM

eCTD publishing

Job description

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.

Please also be aware that all job postings will be listed on our website at spyre.com/careers/.