Senior Manager, Regulatory Affairs CMC

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified checked Jun 13, 2026

Salary

$150K-$176K From the posting source

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Role

Seniority

Senior From the posting source

Work mode

Remote From the posting source

In-office days

0 days From the posting source

Schedule

Shift type

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Weekend work

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Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

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Assessment

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Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Senior Manager, Regulatory Affairs CMC US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. 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

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