HOW MIGHT YOU DEFY IMAGINATION?

　　You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

　　Regulatory Affairs Manager - CMC

　　Live

　　What you will do

　　Let’s do this. Let’s change the world. In this vital role you will provide regulatory strategy for lifecycle management (commercial) products. This position supports Amgen’s marketed products globally, but with direct responsibility to support post-approval change management activities in the US, EU, CN, and JP. The Manager will follow standard department and global marketing/clinical trial template processes to drive consistency and efficiency across programs.

　　Key responsibilities include:

　　Responsibility for the generation and execution of country specific regulatory strategies

　　Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments

　　Development of global dossiers for CMC content, primarily for post approval variations to existing CTAs for marketed products

　　Development of post-approval submissions including maintenance of commercial and clinical applications for US, CA, CN, and/or JP

　　Support Change Management activities

　　Respond to regulatory agency questions

　　Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution, and supply plans

　　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.

　　Participate as an active member of cross-functional teams including Global Regulatory, Operations and Quality as needed

　　Win

　　What we expect of you

　　We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

　　Basic Qualifications:

　　Doctorate degree

　　Or

　　Master’s degree and 3 years of Regulatory Affairs, Quality, or Operations experience

　　Or

　　Bachelor’s degree and 5 years of Regulatory Affairs, Quality, or Operations experience

　　Or

　　Associate’s degree and 10 years of Regulatory Affairs, Quality, or Operations experience

　　Or

　　High school diploma / GED and 12 years of Regulatory Affairs, Quality, or Operations experience

　　Preferred Qualifications:

　　Master’s or Bachelor’s degree or equivalent

　　Regulatory Affairs, Quality, or Operations experience

　　Creation and execution of regional regulatory strategies

　　CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products

　　Direct experience with International market applications – MAAs or variations

　　Good understanding or direct experience of ex US filings

　　Excellent communication skills with ability to communicate across all levels

　　Project management skills with ability to work well with others in demanding situations

　　Ability to work in a fast-paced environment

　　Current knowledge and application of CMC hot topics and knowledge of International legislation and guidance for biotechnology products

　　Strong MS Office skills

　　Thrive

　　What you can expect of us

　　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.

　　Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

　　Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

　　A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

　　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 now

　　for a career that defies imagination

　　Objects in your future are closer than they appear. Join us.

　　careers.amgen.com

　　Amgen is an Equal Opportunity employer and will consider you without regard to your 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.