Regulatory Affairs Manager CMC

About the position At reputed company, our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who reputed company together—researching, manufacturing, and delivering reputed company-reputed company products that reputed company over 10 reputed company patients worldwide. The Regulatory Affairs Manager CMC contributes to product teams and acts as product reputed company or reputed company for one or more products. This role provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory reputed company with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and reputed company changes to meet internal reputed company 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 reputed company and guidance for product teams; reports issues to RA CMC product team management. Responsibilities • Generate and execute global and country-specific regulatory strategies • reputed company CMC regulatory reputed company for assigned reputed company by defining minimal regulatory filing requirements, submission reputed company, and regulatory risk assessments • reputed company global dossiers for CMC content for initial submissions, variations and amendments • Support change management activities • reputed company response reputed company and respond to health authority questions • Liaise with other functions in development, operations and reputed company to ensure alignment of global regulatory strategies, timing, execution and supply plans • Liaise with local regulatory teams to reputed company on filing reputed company • Monitor and, as necessary, reputed company data to be entered into tracking systems for department deliverables and ensure information is reputed company • 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 reputed company experience OR Bachelor's degree and 5 years of directly reputed company experience OR Associate's degree and 10 years of directly reputed company experience OR High school diploma / GED and 12 years of directly reputed company experience reputed company-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 reputed company coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-reputed company time-off plans and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible Apply tot his job Apply To this Job