Senior Regulatory Affairs Associate

Position Overview Senior Specialist, Regulatory Operations: Responsible for submission management across the development pipeline and support the commercial portfolio. Hands‑on role assisting regulatory affairs systems, applications, and tools (system implementations, maintenance, updates, and releases). Works with Regulatory Affairs and cross‑functional partners to manage timelines and submission readiness. Reports to the Senior Director of Regulatory Affairs; office‑based or remote. Essential Duties Lead end‑to‑end management of regulatory submissions, ensuring timely, compliant, high‑quality deliverables. Interface with external publishing vendors and internal stakeholders to provide operational oversight/support for eCTD regulatory submissions. Serve as submission manager and primary contact for publishing vendors and internal stakeholders. Oversee regulatory document management, tracking, and archival. Manage regulatory systems (e.g., Veeva RIM, PromoMats); act as internal SME for training/support. Develop and implement processes, templates, and tools to improve submission efficiency/consistency. Partner with IT to maintain regulatory technology landscape (maintenance, updates, releases). Provide regulatory technology and submission best‑practices expertise. Monitor new regulations/industry trends and assess impact on operational practices. Perform other supporting activities/research as needed. Necessary Skills/Abilities Experience managing outsourced publishing vendors (plus). Balance strategic oversight with hands‑on execution. Strong communication/collaboration and organizational skills. Ability to travel 10%. Educational Requirements Bachelor’s degree in a scientific or related field. Experience Requirements 3–4 years regulatory operations experience in biotech/pharma. Strong understanding of eCTD standards and global regulatory requirements. Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management. Hands‑on Veeva RIM and/or PromoMats strongly preferred. Compensation & Benefits Medical, dental, vision, life/AD&D, short‑/long‑term disability, FSAs, HSA, Employee Assistance Programs; pet insurance; 401k with company match and annual discretionary stock options; paid time off, sick time, paid holidays; career development/training. #J-18808-Ljbffr