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.
Regulatory Affairs Director - General MedicineLive
What you will do
Lets do this. Lets change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the General Medicine Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.
The responsibilities of the Regulatory Affairs Director position are:
Develop and execute the global regulatory product strategy
Represent Regulatory on the product team and other key commercialization governance bodies
Develop Global Regulatory Strategic Plan and provide regulatory input into the products Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Represent GRA on the product team
Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy
Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
Attend key regulatory agency meetings which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Doctorate degree and 4 years of regulatory experience in biotech or science OR Masters degree and 8 years of regulatory experience in biotech or science OR Bachelors degree and 10 years of regulatory experience in biotech or science
Ability to lead and build effective teams
Strong communication skills - 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
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
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
Apply now 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
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.
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.