Spyre Therapeutics · 8 hours ago

Senior Manager, Regulatory Operations

United States

Full-time

Remote

Senior Level, Lead/Staff

$170K/yr - $191K/yr

8+ years exp

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Responsibilities

Oversees and manages all regulatory submissions and submission compliance.

Works on all aspects of creating (i.e., template management and workflow administration), publishing, submitting, and archiving regulatory submissions to various Health Authorities. Ensures consistency, completeness, and adherence to internal standards for all regulatory submissions.

Manages the activities of external publishing staff contracted to publish and dispatch health authority submissions.

Develops, implements, and maintains regulatory standards and best practices for dossier management, publishing, and archiving and provides training to submission contributors.

Evaluates regulatory systems and proposes improvements, if needed. Manages selection, implementation, and maintenance of all Regulatory support systems, including systems subject to computer system validation.

Leads or contributes to overall regulatory project management activities, such as submission planning, timelines, and portfolio level tracking.

Other duties as assigned.

Qualification

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Regulatory OperationsECTD dossier managementRegulatory submission planningVendor oversightDocument managementProject managementMicrosoft SuiteSmartsheetsVeeva RIM systemsSharePointComputer system validationXmlSPLSoft skills

Required

Bachelor’s degree with 8+ years of experience in Regulatory Operations environment within the pharmaceutical industry, with a focus on eCTD dossier management is preferred. In lieu of a degree 10 years of related industry experience is required.

Experience managing multiple active applications.

Experience with ex-US regulatory submissions requirements and processes, including EU-CTR, Canada, Eastern Europe, Latin America, and APAC.

Advanced user of Microsoft suite and Smartsheets.

Demonstrates a willingness to learn new skills and contribute to the team efforts in new ways.

Preferred

Experience with Veeva RIM systems (either as a user or, ideally, as a system administrator) and SharePoint a plus.

Familiarity with computer system validation for FDA/EMA regulated systems a plus.

Understanding of xml and SPL in relation to FDA submissions a plus.

Benefits

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.