Amgen Regulatory Affairs, Manager in Thousand Oaks, California
Amgen is seeking a Regulatory Affairs, Manager to work in their Thousand Oaks, CA or San Francisco, CA location. This position will report to Regulatory Affairs Senior Manager.
The Regulatory Affairs division establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices and in-vitro diagnostics.
Responsibilities of the Regulatory Affairs, Manager include:
Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
Developing regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies.
Providing regulatory input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners.
Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), IDE) submissions.
Review of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities.
Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDx development & registration activities, respectively.
Master’s degree and 2 years of Regulatory experience
Bachelor’s degree and 4 years of Regulatory experience
Associate’s degree and 10 years of Regulatory experience
High school diploma / GED and 12 years of Regulatory experience
Degree in Regulatory Affairs, Life Sciences, or Engineering
4+ years of experience in Regulatory Affairs, including United States and international medical device and/or in-vitro diagnostic product regulations
4+ years of experience in software development, IVD, or companion diagnostics