Director, Regulatory Affairs

Spyre Therapeutics

. Manage and oversee regulatory affairs activities and execution, initially focused on Spyre’s IBD program .

Posted 10/30/2026full-timeUnited StatesLead💰 $220,000 - $245,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing regulatory affairs, including clinical trial applications and global submissions, while effectively communicating with health authorities and cross-functional teams. Proficient in developing regulatory strategies and ensuring compliance with FDA, EMA, and ICH guidelines.

Highest-signal resume keywords

Regulatory Affairs ManagementClinical Trial ApplicationsGlobal Pharmaceutical RegulationsMedical Writing ProficiencyLeadership and Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical Development PlansRegulatory StrategiesRegulatory ApplicationsCMC Regulatory KnowledgeTechnical WritingRegulatory Risk AssessmentRegulatory CompliancePharmaceutical GuidelinesInvestigational New Drug Applications

Soft Skills

LeadershipCommunicationInterpersonal SkillsProblem-SolvingCritical Thinking

Tools & Technologies

Regulatory Affairs SoftwareDocument Management Systems

Industry Keywords

FDAEMAICHClinical TrialsPharmaceutical IndustryPreclinical DevelopmentHealth Authority InteractionsRegulatory Affairs BudgetsCompanion DiagnosticsAuto-Injectors

About the role

Key responsibilities & impact

Manage and oversee regulatory affairs activities and execution, initially focused on Spyre’s IBD program
Plan and execute regulatory strategies enabling clinical trial initiation and management
Contribute to preclinical, CMC, and clinical development plans to support product approvals
Lead global regulatory applications for one or more drug candidates
Lead original investigational new drug and clinical trial application submissions
Plan and prepare meetings with global health authorities, including FDA Type C and EOP2 meetings and EMA scientific advice
Support live discussions with health authorities
Develop and implement regulatory strategies for clinical trials and marketing applications
Prepare, review, and submit regulatory applications and dossiers to FDA, EMA, PMDA, and other global agencies
Develop briefing materials, capture action items, and support health-authority meeting implementation and strategy
Represent the company in regulatory interactions and respond to agency inquiries and requests
Communicate regulatory interactions and guidance to leadership and cross-functional teams
Identify regulatory risks and develop mitigation strategies
Monitor regulatory landscapes and assess impacts on company products
Track evolving regulations, guidelines, and pharmaceutical-industry best practices
Collaborate with Pre-clinical R&D, Clinical Development, Technical Operations, Legal, Quality, and Compliance
Contribute to development and management of regulatory affairs budgets

Requirements

What you’ll need

Bachelor’s degree with 8-10 years of experience in pharmaceutical regulatory affairs and/or related disciplines, or an equivalent combination of relevant education, training, and experience
Proven track record of successfully managing complex regulatory submissions
Proven experience managing clinical trial applications in the US and globally
Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
Proficient in medical and/or technical writing, including authoring or contributing to Module 2 and 3 summaries, DSURs, safety reports, investigational brochures, clinical trial protocols, clinical trial reports, and/or IMPDs
Excellent leadership, communication, and interpersonal skills
Strong problem-solving and critical thinking abilities
Ability to meet deadlines and adapt to changing priorities
Proficiency in regulatory affairs software and document management systems
Experience with CMC regulatory, devices such as pre-filled syringes and/or auto-injectors, and/or diagnostics such as companion diagnostics

Benefits

Comp & perks

Market competitive compensation and benefits package
Performance bonus
Equity grant opportunities
Health, welfare & retirement benefits
Unlimited PTO
Two, one-week company-wide shutdowns each
Professional development opportunities
Remote working environment with frequent in-person meetings
Opportunity to work in a fast-paced, dynamic environment, help shape company culture, contribute to meaningful medicines, and learn quickly