Senior Regulatory Specialist

Regulatory Document Manager – Veeva RIM, Module 5 A World Class Company Osprey Life Sciences, LLC is a leading consulting and services firm specializing in providing comprehensive technology solutions for Life Sciences IT organizations. Our primary focus is on assisting these organizations in effectively and efficiently delivering solutions that support their business objectives and their mission to enhance human health and improve lives. Overview Osprey Life Sciences is seeking a Regulatory Document Manager – Veeva RIM, Module 5 to support clinical content preparation and execution for a Biologics License Application (BLA). This role will provide operational coordination and content governance for Module 5 – Clinical Study Reports , ensuring documents progress efficiently through the Veeva RIM lifecycle while maintaining quality, submission readiness, and cross-functional alignment. The ideal candidate combines Regulatory Affairs and clinical submission experience with hands‑on knowledge of Veeva RIM/Vault document workflows and the ability to coordinate authors, reviewers, and functional stakeholders in a fast-paced submission environment. Responsibilities Own and coordinate assigned Module 5 documents within Veeva RIM/Vault throughout the document lifecycle. Manage document workflows, states, versioning, review cycles, approvals, and associated metadata. Coordinate clinical authors, reviewers, Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and other contributing functions. Track document development against BLA timelines, milestones, and dependencies. Facilitate review cycles and ensure comments are appropriately adjudicated, documented, and resolved. Identify document gaps, workflow issues, and potential risks to submission timelines and elevate as appropriate. Maintain accurate document status and provide visibility into progress, outstanding actions, and upcoming deadlines. Ensure documents meet established standards for quality, completeness, traceability, and submission readiness. Support final approval, publishing handoffs, and overall BLA submission readiness. Maintain continuity and governance of Module 5 content throughout the BLA lifecycle. Qualifications Bachelor’s degree in a scientific, life sciences, healthcare, regulatory, or related discipline. 4+ years of Regulatory Affairs, clinical regulatory, or submission-related experience , with experience supporting Module 5 or clinical submission content strongly preferred. 1–2+ years of hands‑on Veeva Vault/RIM experience , including document workflows, review cycles, approvals, and lifecycle management. Experience supporting BLA, NDA, MAA, or other major regulatory submissions strongly preferred. Understanding of eCTD Module 5 content , including Clinical Study Reports and supporting clinical documentation. Experience coordinating cross-functional document authors and reviewers. Strong organizational skills with the ability to manage multiple documents, dependencies, and deadlines simultaneously. Excellent communication, follow-through, and stakeholder-management skills. Ability to operate effectively in a highly regulated, deadline-driven environment. Preferred Experience Direct experience supporting a BLA submission . Experience working with clinical development and regulatory teams in biotechnology or pharmaceutical organizations. Familiarity with submission content planning, document readiness tracking, and regulatory publishing handoffs. Experience supporting late‑stage or pre-commercial programs through regulatory submission. We offer an excellent compensation and benefits package with challenge and opportunity to learn, grow and contribute to a stimulating, fast‑paced environment. Osprey is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. #J-18808-Ljbffr Osprey Life Sciences