Amgen Regulatory Affairs Manager, Oncology in Thousand Oaks, California
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. 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 Regulatory Affairs Manager, under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. This position is located at our Thousand Oaks, campus.
Responsibilities of the Regulatory Affairs Manager include:
Assist Regional Regulatory Lead (RRL) to support US Regional Regulatory Activities (e.g. IND development and submission, advisory committee meeting preparations).
Create and maintain product regulatory history documents through Insight Management for Regulations (IMR) and appropriately archive all regulatory documents and agency communications.
Review regional component of the Global Regulatory Plan and provide input to operational deliverables; perform regulatory research to support the development of content for Global or Regional regulatory plan as delegated by the Global or Regional regulatory lead.
Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies.
Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
Participate in GRT and assist the Global or regional regulatory lead in meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes.
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages).
Support the development and execution of GRT goals.
Bachelor’s degree and 2 years of regulatory or drug development experience
Associates degree and 6 years of regulatory or drug development experience
High school diploma / GED and 8 years of regulatory or drug development experience
Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
Regulated industry, science or clinical practice experience
Good communication skills - both oral and written
Organizational skills - detail oriented and can deal with frequent changes in product activity
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.