HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Regulatory Affairs Manager – CMC
Live
What you will do
Lets do this. Lets change the world. In this key role you will manage an external service provider and internal staff members within the Regulatory Optimization of Tactical and Strategic Support (Roots2) team. ROOTS2 is a team within the Global CMC Regulatory Affairs department responsible for execution of CMC submissions across countries, using standardized procedures to improve efficiency. This role will also manage, lead, and develop CMC regulatory staff in US and/or UK. This role requires a strong understanding of the CMC regulatory requirements across countries, phases of development and indications for biologic, synthetic, and/or biosimilar products as well as the ability to coordinate resources and tasks across Amgen global sites.
Key responsibilities of this CMC Regulatory Manager role include:
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Oversight of an external service provider including, but not limited to, direct interactions with the vendor, oversight of resources and ways of working
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Supervising assigned team members with respect to management, training, and resource planning
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Support of CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for information across countries
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Collaboration with leadership across CMC Regulatory functions and other functional leaders
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Leading process improvements and documenting CMC Regulatory processes
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Providing expertise and guidance to interdepartmental and cross-functional teams
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Coaching and supporting junior staffs career development
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
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Doctorate degree; OR Masters degree and 3 years of Regulatory CMC or Compliance and/or Quality experience; OR Bachelors degree and 5 years of Regulatory CMC or Compliance and/or Quality experience; OR Associates degree and 10 years of Regulatory CMC or Compliance and/or Quality experience
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CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
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Preparation of global CMC submissions across all phases of development
Preferred Qualifications:
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Degree in life sciences, biochemistry, or chemistry
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Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
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Experience with manufacturing, process development, quality control, or quality assurance
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Experience with training and/or managing staff
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Project management experience
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.
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Full support and career-development resources to expand your skills, enhance your expertise, and increase your potential along your career journey
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A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
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Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Join UsIf 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.