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Global CMC Regulatory Affairs – Senior Manager

amgen

This is a Full-time position in Los Angeles, CA posted July 30, 2022.

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Global CMC Regulatory Affairs – Senior Manager Live What you will do Let’s do this. Let’s change the world. Amgen is seeking a Global CMC Regulatory Affairs – Senior Manager. The Global CMC Regulatory Affairs – Senior Manager will work out of the site in Cambridge MA, or our main corporate campus in Thousand Oaks, CA, or remotely. The role will assume a Global regulatory CMC lead role for early development clinical programs. Amgen is searching for a Global CMC Regulatory Affairs – Senior Manager to work out of the site in Cambridge MA, or our main corporate campus in Thousand Oaks, CA, or remotely. The Global CMC Regulatory Affairs – Senior Manager will provide regulatory strategy for early development clinical programs, including determining regulatory reporting and global filing requirements for changes. The Senior Manager will preferably have direct Regulatory CMC submission experience. The Senior Manager will facilitate the communication of regulatory requirements and strategies to the Process Delivery Team (PDT) and different functional areas; thus, the Senior Manager will need strong leadership and written and verbal communication skills. The Senior Manager will follow standard department and global processes to drive consistency across clinical programs and may contribute to departmental or cross-product initiatives. Key responsibilities of the Senior Manager in Regulatory Affairs (CMC) include: Defining minimum regulatory filing requirements for early development clinical programs Providing regulatory strategy through development of strategic plans and/or documentation of global regulatory strategies for filing changes Driving authoring and submission of clinical CMC filings and maintaining regulatory applications Maintaining product compliance through appropriate regulatory filings and activities Supporting change management activities Responding to regulatory Agency questions Facilitating Agency interactions, including preparation of meeting requests and briefing documents Liaising with other Functional areas in commercialization, operations, and lifecycle to ensure alignment of global regulatory strategies, timing, and execution Contributing to PDT strategies Monitoring and, as necessary, providing data to be entered into tracking systems for department deliverables and ensuring information is current Participating as an active member of cross-functional teams including Global Regulatory Team (GRT), PDT, etc., as needed. 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 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 Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.