US Regulatory Affairs Manager
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.
US Regulatory Affairs ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Assist the Global Regulatory Lead (GRL) to support US Regulatory Activities (e.g. IND development and submission, advisory committee meeting preparations)
- Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
- Review the regional component of the Global Regulatory Plan and provide input to operational deliverables; perform regulatory research to support the development of content for Global regulatory plan as delegated by the Global regulatory lead
- Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
- Assist the Global Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions
- Participate in the Global Regulatory Team (GRT) and assist the Global Regulatory Lead in meeting management (e.g. agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Support the development and execution of GRT goals
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hardworking professional we seek is a partner with these qualifications.Basic Qualifications
- Doctorate degree Or
- Masters degree and 3 years of regulatory or drug development experience Or
- Bachelors degree and 5 years of regulatory or drug development experience Or
- Associates degree and 10 years of regulatory or drug development experience Or
- High school diploma / GED and 12 years of regulatory or drug development experience
- Masters degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
- Regulated industry, science or clinical practice experience
- Good communication skills - both oral and written
- Organizational skills - detail oriented and can deal with frequent changes in product activity
Some of the vast rewards of working here
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.
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
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.