Director Regulatory Affairs - CMC
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Director Regulatory Affairs -CMCLive
What you will do
Let’s do this. Let’s change the world. In this vital role, you will lead the manufacturing site regulatory activities to facilitate product development and global registration of Amgen products. This is completed by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
You would be joining the Site Chemistry, Manufacturing and Controls Regulatory team, a global team which operates from Amgen manufacturing facilities across the globe. The team is part of the Global CMC Regulatory organization that supports Amgen’s diverse global portfolio of investigational and commercially approved products. The Site CMC Regulatory team, in collaboration with our global, international & local regulatory affiliates is responsible for developing CMC product strategy and the execution and delivery of regulatory submissions supporting the continued success of our manufacturing facilities.Specific responsibilities include but are not limited to:
- Leading one or more Site CMC Regulatory Teams within Amgen’s Global Regulatory Affairs department.
- Educational background in Life Sciences, Chemistry or Engineering
- Leading the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site
- Overseeing the strategy and execution of site-specific aspects of CMC investigational product amendments, marketing applications, post-market supplements, and periodic notifications
- Coordinating site-specific change control regulatory assessments with input from CMC product teams and the CMC regulatory representatives.
- Managing prioritization of and resource planning for multiple products across site(s).
- Mentoring and developing a team of regulatory professionals at various levels.
- Representing CMC regulatory on product deviation investigation teams, Operations and Quality steering committees, and review boards.
- Identifying process improvements to align with internal Amgen initiatives and changes in external regulatory policy and guidance.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Doctorate degree and 4 years of regulatory experience in biotech, manufacturing environment.
Master’s degree and 8 years of regulatory experience in biotech, manufacturing environment.
Bachelor’s degree and 10 years of regulatory experience in biotech, manufacturing environment.And
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Ability to lead and build effective teams
- Strong communication skills in English across all levels – both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and mitigate against future strategic issues & uncertainties
- Ability to resolve conflicts and develop a course of action
- Cultural awareness and sensitivity to achieve global results
- Able to prioritize and manage multiple activities
- Ability to make complex decisions and solve problems
- CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products
What you can expect of us
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.
- 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
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.com
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.