Senior Manager, Regulatory Affairs

Regulatory Jobs; United States; Hybrid; USD 160,000 - 176,000; Full time

Benefits offered by this job

Unlimited PTO

Equity grant opportunities

Remote work option

Health benefits

Job summary

Spyre Therapeutics is seeking a Senior Manager, Regulatory Affairs to lead regulatory planning and execution for global Phase 3 programs. You will drive submission plans, author and review critical documents, and coordinate CRO oversight while reporting to Regulatory Affairs leadership.

Ideal candidate brings 5–7+ years in pharma regulatory affairs, with strong FDA/EMA knowledge, regulatory writing skills, and cross-functional collaboration capabilities in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree required with 5–7+ years in pharma regulatory affairs.
• Experience contributing to study-level regulatory strategies and submission plans.
• Proven ability to manage CROs and cross-functional teams.
• Strong knowledge of FDA, EMA, ICH requirements and regulatory writing.
• Excellent communication and project-management skills.

Responsibilities

• Develop regulatory strategies and submission plans for global studies.
• Prepare and coordinate clinical trial applications, amendments and reports.
• Lead submission planning and country-specific regulatory activities.
• Oversee CROs and vendors to ensure quality and timeliness.
• Support health authority interactions and briefing materials.
• Identify risks and propose mitigation actions.
• Monitor evolving regulations and share practical implications.
• Support audits, inspections, and process improvements.

Skills

Regulatory strategy

Global submissions

FDA/EMA knowledge

Regulatory writing

CRO oversight

Cross-functional collaboration

Project management

Veeva RIM experience

Smartsheet / Excel

Education

Bachelor's degree

Advanced degree (a plus)

Tools

Veeva RIM

Smartsheet

Microsoft Excel

Job description

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, and IL-17A/F as well as rational combination programs.

As Senior Manager, Regulatory Affairs, you will play a key role in supporting regulatory planning and execution, initially focused on Spyre’s global Phase 3 clinical program, with the opportunity to contribute across the organization. Reporting to the Associate Director, Regulatory Affairs, this hands‑on role will support study development, global study start‑up, and clinical trial application lifecycle management.

You will work closely with regulatory leadership and cross‑functional project teams to establish regulatory plans, applications, processes, and define priorities. You will independently manage assigned deliverables, including submission planning and execution, document preparation and review and CRO oversight, while progressively assuming day‑to‑day regulatory leadership for designated studies within the overall program direction and regulatory strategy led by the Associate Director.

You will identify regulatory risks and align regulatory activities across Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, CMC, Nonclinical, and Quality. You will also provide practical regulatory input to study documents and support health authority interactions and responses. This role requires strong communication and collaboration skills to resolve complex regulatory issues, align project teams, and adapt quickly to drive work forward in a fast‑moving, dynamic environment.

Key Responsibilities:

• Regulatory Strategy and Planning: Support the development and implementation of regulatory strategies for assigned studies. Create and maintain submission plans, country‑level timelines, document requirements, and executive dashboards for global study start‑up and ongoing study conduct.
• Document Preparation and Review: Contribute to and coordinate preparation and review of clinical and regulatory documents, including protocols, amendments, informed consent templates, investigator’s brochures, briefing documents, and country‑specific submission documents. Ensure cross‑document consistency and manage documents through the applicable document management system.
• Regulatory Submissions: Prepare, compile, review, and coordinate clinical trial applications and related submissions to the FDA, EMA/EU Member States, and other global health authorities in coordination with global CRO partners. This includes original INDs/CTAs, substantial amendments, annual reports, DSURs, and responses to health authority requests for information.
• CRO and Vendor Oversight: Manage regulatory activities performed by CROs and vendors within agreed study plans and timelines. Establish clear expectations, track deliverables, review country‑specific submission packages for quality and completeness, drive issue resolution, and elevate significant quality, timeline, compliance, or program‑level risks with impact assessments and recommended actions.
• Health Authority Activities: Support health authority interactions and meeting preparation with the Associate Director and Regulatory Affairs leadership by coordinating cross‑functional input, contributing to briefing materials, managing response development, and ensuring commitments and follow‑up actions are completed.
• Risk Identification: Anticipate regulatory risks and bottlenecks that could affect study timelines, propose practical mitigations, and elevate issues promptly to Regulatory Affairs leadership with clear options and recommendations.
• Regulatory Intelligence: Monitor evolving regulations, guidance, and country‑specific requirements relevant to the therapeutic area and stage of development and share practical implications with the team.
• Process and Compliance: Contribute to Regulatory Affairs processes, templates, and trackers, and support audit and inspection readiness for assigned studies.
• Other duties as assigned.

Ideal Candidate:

• Minimum of Bachelor’s required; degree and 5-7+ years of experience in pharmaceutical regulatory affairs and/or related disciplines required advanced degree in a related disciplines is a plus.
• Demonstrated ability to contribute to study‑level regulatory strategies, and develop submission plans, timelines, document requirements, and trackers to support global study start‑up and ongoing study conduct.
• Experience managing clinical regulatory submissions in US, EU CTR and globally, including initial applications, amendments, health authority responses, multi‑country study start‑up, and ongoing application maintenance.
• Experience overseeing CROs and vendors to deliver compliant regulatory submissions on schedule.
• Strong knowledge of global pharmaceutical regulations and guidance, including FDA, EMA, and ICH requirements.
• Proficient in regulatory/technical writing, including authoring or contributing to clinical trial protocols and amendments, informed consent templates, investigator’s brochures, DSURs, safety reports, briefing documents, and IMPDs.
• Excellent communication, interpersonal, and collaboration skills, with a team‑first approach and a track record of building trust across functions and with external partners.
• Strong organizational and project management skills, with the ability to meet deadlines, prioritize competing demands, and manage multiple submissions simultaneously.
• Proficiency with regulatory affairs software, document management systems such as Veeva RIM, and tracking tools such as Smartsheet or Excel.
• Familiarity with combination product/device (e.g., pre‑filled syringe and/or auto‑injector) considerations is a plus.

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 $160,000 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.