1 associate manager regional operations jobs found

Alkermes, Inc. The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. You'll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. Key Responsibilities: Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables. This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. Serve as submission manager and primary contact for publishing vendors and internal stakeholders....