Senior Manager - Regulatory Operations

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Spyre Therapeutics

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Description

• Spyre Therapeutics is a clinical-stage biotechnology company focused on IBD products. • The Sr. Manager, Regulatory Operations will manage regulatory submissions, project management, and compliance. • Oversees all regulatory submissions and ensures adherence to internal standards.

Requirements

• 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. • 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

• 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.