Regulatory Affairs Manager CMC
About the position At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. The Regulatory Affairs Manager CMC contributes to product teams and acts as product lead or principal for one or more products. This role provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management. Responsibilities • Generate and execute global and country-specific regulatory strategies • Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments • Develop global dossiers for CMC content for initial submissions, variations and amendments • Support change management activities • Develop response strategy and respond to health authority questions • Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans • Liaise with local regulatory teams to align on filing strategy • Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current • Maintain submission information according to the Regulatory Information Management (RIM) system • Follow established department regulatory processes to ensure cross-product alignment Requirements • Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Nice-to-haves • Experience in manufacture, testing (QC/QA or clinical), or distribution • Regulatory CMC experience Benefits • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible Apply tot his job