Regulatory Labeling Sr Mgr
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Regulatory Labeling Sr MgrLive
What you will do
Lets do this. Lets change the world. In this vital role you will
Directs strategic content for Labeling within a TA (including dCDS/cCDS, dIFU/cIFU, cPIL, maintenance agreements, and other core components)
- Accountable for strategic and tactical guidance to product labeling review teams regarding labeling development and maintenance of corporate labeling documents
- Accountable to partner with Human Factors and Quality Engineers to ensure comprehensive and driven IFUs within Design Control procedures
- Ensures labeling processes support the development of accurate, current consistent, comprehensive and driven global labeling
- Reviews and comments on the internal and external guidelines and regulations related to regulatory, safety, and legal topics
- Accountable for ensuring compliance with global regulatory requirements and adherence to internal regulatory policies and processes
- Provides advice and support to the Labeling Strategist on key labeling decisions or on escalation of decisions involving labeling review committees (e.g. Labeling Working group, Executive Labeling Board or Senior Management Team)
- Chairs the Executive Labeling Board
- Provides input and strategic guidance to the Target Product Label.
- Independently makes decisions regarding complex operations, processes or business practices.
- Supports creation and administration of department/labeling training programs.
- Leads or participates in internal and external (cross functional or health authority/industry) special projects (improvement initiatives, strategic planning, and labeling guidance documents)
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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.Thrive
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsWin
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients.Doctorate degree and 4 years of related experience
OR Masters degree and 8 years of related experienceOR Bachelors degree and 10 years of related experience
AND 4 years of managerial experience directly running people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Degree in pharmaceuticals, natural science or medicine Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling Experience in the development and maintenance of core and product Labeling Strong understanding of scientific principles relevant to drug development and product labeling Organizational specialist within defined subject area Experience in Medical Device industry, including Design Controls and Human Factors principles Experience with combination products/drug delivery systems Knowledge of FDA, EMA, and other international regulations for labeling Management oversight of sophisticated projects.
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.