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. With a deep and broad pipeline of potential new medicines, we continue to advance science and serve patients.
Accountable for the development and execution of regulatory strategies, plans, and marketing applications for biosimilar products.
- Provide regulatory expertise and guidance to the cross-functional teams on regulatory requirements related to global clinical development plans and marketing registrations
- Lead development of high quality regulatory documents (CTAs, Marketing Applications, and Responses to Health Authority questions) with the focus on clinical/non-clinical aspects
- Support development and execution of global clinical/non-clinical development strategies
- Manage the development of global product labels and core data sheets to align commercial objectives with regulatory expectations
- Collaborate and effectively communicate with partners and Amgen affiliates as required to ensure implementation of global
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning
- Provide regulatory risk assessment to the GRAAS Biosimilars function
- With minimal supervision, participate in development and execution of risk management and contingency planning
- Ensure and lead regulatory compliance for biosimilar products (i.e., PMCs and other agency commitments)
- Participate and lead team preparations for regulatory interactions with Health Authorities
Amgen's outstanding compensation package features comprehensive benefits. To learn more about this opportunity and to apply, please visit us online at www.amgen.com/careers and search job #23418BR.
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.