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 Live What you will do Lets do this.
Lets change the world.
Amgen is seeking a Regulatory Affairs Manager (CMC).
The Regulatory Affairs 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.
Regulatory strategies securing regulatory approvals, and maintenance of product licenses Interpret results, author technical protocols, reports, analytical method descriptions and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
Provide provision and insight to implement CMC regulatory strategies Collaborate with Amgen partners to develop and complete CMC regulatory activities Develop, communicate, and implement global strategies in support of department goals and product portfolio Ensure regulatory documents (including quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents) are developed and delivered in a timely manner Implements regulatory strategy with respect to preparation of submissions; align with critical RA CMC processes Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities Prepare for and participate in CMC-related agency interactions Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance Escalate CMC issues, progress, and metrics contributes to process improvements Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams Determine minimum filing requirements Represent RA CMC on committees Win What we expect of you As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Basic Qualifications: Doctorate degree OR Masters degree and 3 years of Regulatory CMC & Compliance and/or Quality experience OR Bachelors degree and 5 years of Regulatory CMC & Compliance and/or Quality experience OR Associates degree and 10 years of Regulatory CMC & Compliance and/or Quality experience OR High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience Preferred Qualifications: 3 years experience in regulatory, project management and product development in the Pharmaceutical/Biotechnology industry, preferably CMC Degree in life sciences, biochemistry or chemistry Experience managing multiple projects Knowledge and understanding of different phases of drug development CMC-specific regulatory knowledge & experience with solid working knowledge of Clinical Trial Disclosure (CTD) Develop solutions to technical and organizational issues in order to improve performance and productivity Strong computer skills, including word processing, Excel, database/document repository and project management software 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.