Amgen is seeking a Regulatory Affairs Global Lead-Oncology to work out of our Thousand Oaks, CA location. This position reports to the Executive Director of Regulatory Affairs.
In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.
We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.
Amgen offers the opportunity to devise, develop and implement creative global regulatory strategies to bring novel products to patients as quickly, robustly and efficiently as possible and to shape the regulatory framework in which we operate.
The purpose of this role is:
To lead one or more GRTs and other regulatory staff within Amgen's Global Regulatory Affairs department
To 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
To provide regulatory expertise and guidance to product teams (eg, Product Strategy Team PST)
The Responsibilities of the Global Regulatory Affairs position are:
Develop and execute the global regulatory product strategy & lead global regulatory teams.
Represent Global Regulatory Affairs (GRA) on the Product Strategy Teams (PT) and other key commercialization governance bodies.
Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan.
Registration strategies and development 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 implementing 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's, and current regulatory environment.
Produce strategies that provide innovative alternatives which communicate the associated risks.
Interact with Global regulatory agencies, in collaboration with regional colleagues.
Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams).
Integrate regional regulatory representative input into GRT and regulatory plans.
Represent GRA on key commercialization teams (e.g, PST, GDT, GST).
Represent Amgen GRA on external partnership teams at the PST level.
Provide education and training on regulatory strategies and compliance issues to other functions.
Doctorate degree and 4 years of Regulatory experience
Master's degree and 8 years of Regulatory experience
Bachelor's degree and 10 years of Regulatory experience
4 years of managerial experience directly managing people and/or leadership experience leading teams,
projects, programs or directing the allocation of resources
Current experience developing novel global oncology product regulatory strategies including submissions and approvals of marketing applications
Ability to lead and build affective 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
Making complex decisions & setting priorities
Dealing with ambiguity
Conflict management skills
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.#LI-SF5
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.