Director Global Regulatory Labeling (Open to Remote)
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.Director Global Regulatory Labeling - Open to RemoteLive
What you will do
Lets do this. Lets change the world. The purpose of the Global Regulatory Labeling (GL) group is to ensure safe and effective use of Amgen products for patients and healthcare providers around the world by driving global labeling strategy and developing and maintaining core labeling documents to provide quality product labels. The Head of Global Labeling, reporting to the Head of Global Regulatory Affairs Execution Team (GRAET), directs and leads the Labeling Strategists within the Therapeutic Areas. The Head of Global Labeling is a member of the Global Labeling Leadership Subteam within the GRAET Leadership Team, with accountability for the strategic labeling content over the entire product life cycle. The Head of Global Labeling could concurrently be a Labeling Strategist for one or more products.
- Accountable and responsible for providing strategic leadership and oversight of pharmaceutical and device global product labeling content and compliance throughout the product life cycle
- Develop a strong team of professionals to ensure Amgen achieves and maintains the best label for the product globally.
- Accountable for global understanding of labeling guidance and precedent
- Accountable for influencing future labeling guidance and policies
The Head of Global Labeling has the following responsibilities:
- Responsible for Global Labeling worldwide for all therapeutic areas and drives strategy accordingly.
- Provide leadership to the Therapeutic Area Leads and Labeling Strategists who manage the labeling for all Amgen compounds.
- Works across the Amgen product portfolio to drive consistency of key labeling claims across product labels.
- Provides strategic direction and oversight for global labeling regulatory policy issues, including external influence through advocacy and membership on key industry working groups, and direct interaction with health authorities and policy makers.
- Represent Global Labeling on governance bodies, with internal and external partners and with regulatory bodies.
- Supports creation and administration of department/labeling training programs.
- Troubleshoots and solves any conflicts or issues approaching or on the critical path to reaching a labeling decision.
- Sponsor company-wide understanding of key labeling requirements.
- Accountable for hiring, mentoring, development and succession planning of staff.
- Accountable for workload and resource distribution within the team.
Open to remote work arrangement. Travel requirement is approximately 20%.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.
- Doctorate degree and 4 years of labeling experience
- OR Masters degree and 8 years of labeling experience
- OR Bachelors degree and 10 years of labeling experience
- AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Degree in pharmacy, pharmaceuticals, natural science or medicine
- Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
- Experience in Medical Device industry, including Design Controls and Human Factors principles
- Experience with combination products/drug delivery systems
- Experience in the development and maintenance of core product labeling
- Knowledge of FDA, EMA, NMPA, PMDA and other international regulations for labeling
- Strong understanding of scientific principles relevant to drug development and product labeling
- Management oversight of complex projects
- Experience interacting with regulators during inspections
- Accomplish business results through teams
- Ability to take initiative and drive results
- Tolerance for ambiguity
- Problem anticipating and solving ability with demonstrated generation of alternative solutions prior to elevation of issues to management
- Strong communication, interpersonal, and leadership skills
- Understanding the impact of emerging regulatory requirements and their implications for Amgen
- Influencing and negotiation skills
- Organizational expert within regulatory labeling
- Applies expert knowledge and broad understanding of multiple disciplines
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 benefits
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.
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.