Regulatory Affairs Manager CMC

You will need to login before you can apply for a job. If you feel like you're part of something bigger, it's because you are. 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 by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Regulatory Affairs Senior Manager Regional Regulatory Lead Job Description How might you defy imagination? If you feel like you're part of something bigger, it's because you are. 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 by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Live What you will do Let's do this. Let's change the world. The Regulatory Affairs Manager CMC contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and risk assessments; executes regulatory strategy for submissions; complies with RA CMC processes; identifies needs for process and strategy changes; reports issues to management. Key Responsibilities Include: Generate and execute global and country-specific regulatory strategies Provide CMC regulatory strategy for projects, defining minimal filing requirements, submission strategy, and risk assessments Develop global dossiers for CMC content for submissions and amendments Support change management activities Develop response strategies and respond to health authority questions Liaise with development, operations, and commercial teams for alignment Liaise with local regulatory teams for filing strategy alignment Monitor and update data in tracking systems Follow regulatory processes for cross-product alignment Win What we expect of you We seek a leader with these qualifications: Basic Qualifications Doctorate OR Masters + 3 years related experience OR Bachelors + 5 years OR Associates + 10 years OR High school diploma/GED + 12 years related experience Preferred Qualifications Experience in manufacture, testing, or distribution; Regulatory CMC experience Thrive What you can expect of us We support your professional and personal growth, offering comprehensive benefits, bonus programs, stock incentives, time-off, flexible work arrangements, and more. Join us for a career that defies imagination. Objects in your future are closer than they appear. Apply at careers.amgen.com . Application deadline: Ongoing until position is filled. Amgen is an Equal Opportunity employer and provides accommodations for individuals with disabilities. #J-18808-Ljbffr Initial Therapeutics, Inc.