Regulatory Manager – Lifecycle Management

The Regulatory Manager (CMC) will provide regulatory strategy for commercial post-approval products (i.e., lifecycle management), including determining regulatory reporting and global filing requirements for post-approval variations. The Manager will also facilitate the communication of regulatory requirements and strategies to the Process Delivery Team (PDT) and different functional areas. The Manager will follow standard department and global processes to drive consistency across post-approval programs. Key responsibilities of the Regulatory Manager include: o Defining minimum regulatory filing requirements for post-approval programs o Providing regulatory strategy through development of variation strategic plans and/or documenting global regulatory strategies o Driving authoring and submission of post-approval variations and maintaining regulatory applications o Maintaining product compliance through appropriate regulatory filings and activities o Supporting change management activities o Responding to regulatory Agency questions o Facilitating Agency interactions, including preparation of meeting requests and briefing documents o Liaising with other Functional areas in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, and execution o Contributing to PDT variation strategies o Monitoring and, as necessary, providing data to be entered into tracking systems for department deliverables and ensuring information is current o Participating as an active member of cross-functional teams including Global Regulatory Team (GRT), PDT, etc., as needed. (Standard Amgen BQs per level/career track – with appropriate discipline/experience) Basic Qualifications Doctorate degree OR Master’s degree and 3 years of Regulatory CMC & Compliance and/or Quality experience OR Bachelor’s degree and 5 years of Regulatory CMC & Compliance and/or Quality, or related experience OR Associate’s degree and 10 years of Regulatory CMC & Compliance and/or Quality, or related experience OR High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality, or related experience (Top 5-7 preferred qualifications related to the position) Preferred Qualifications Degree in life sciences, biochemistry, or chemistry Experience in leading regulatory CMC submissions Experience with manufacturing, process development, quality control, quality assurance, or regulatory affairs