Regulatory Document Coordinator, Regulatory Affairs

3 days ago

Apply Now

Receive Emails with Similar Jobs

Spyre Therapeutics

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Provide ongoing Word formatting support and final formatting for internally authored documents intended for submission. • Perform final PDF publishing for all submission documents. • Ensure that all final electronic deliverables meet current regulatory electronic document requirements. • Assess publishing and formatting needs and communicate impacts to overall project timelines. • Assist in managing the activities of external publishing staff contracted to publish and dispatch health authority submissions. • Manage document-related tasks including internal workflow management, file transfer, tracking, and archival. • Communicate and provide deliverables to Medical Writers, Quality, Regulatory Leads and others as applicable. • Initiate preliminary drafts of documents for team authoring activities, as needed. • Manage submission archival for ongoing regulatory submissions. • Maintain and update trackers, correspondence logs, and metrics, as needed, to support the Regulatory Team. • File Regulatory correspondence in the Regulatory Information Management (RIM) system. • Collaborate with cross-functional teams to ensure regulatory compliance and submission timelines. • Assist in Veeva RIM management activities. • Serve as the internal subject matter expert (SME) for Accenture Formatting Tool, as a resource for Regulatory and cross-functional authoring teams. • Assist in maintaining regulatory document template library.

🎯 Requirements

• Bachelor’s degree with a minimum of 3 years of experience in a Regulatory Operations environment within the pharmaceutical industry, preferably with a focus on eCTD dossier management. In lieu of a degree, 5 or more years of relevant industry experience is required. • Proven experience managing multiple active regulatory applications simultaneously. • Advanced proficiency with Microsoft Office Suite and Adobe. • Demonstrates adaptability, a strong willingness to learn new skills, and a collaborative approach to supporting team initiatives. • Experience with Veeva RIM systems and SharePoint a plus. • Attention to detail, and excellent organizational and prioritization skills. • Motivated to work in a fast-paced, high-accountability environment. • Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.

🏖️ 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 year. • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.