Career Category

Job Description

Amgen is seeking a Companion Diagnostic Regulatory Affairs Lead, Senior Manager to work in their Thousand Oaks, CA location. This position will report to Director Regulatory Affairs. The Regulatory Affairs lead division establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for in-vitro diagnostics (IVDs)/companion diagnostics (CDx’s).

Responsibilities of the Regulatory Affairs, Senior 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 leadership and 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.
• In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.
• Review and approval 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.
• Regulatory support of due diligence activities of external IVD/CDx companies that Amgen may be considering as partners and other due diligence activities as needed.

Basic Qualifications:

Doctorate degree and 2 years of Health Agency or Med-Device or Regulatory experience
OR
Master’s degree and 6 years of Health Agency or Med-Device or Regulatory experience
OR
Bachelor’s degree and 8 years of Health Agency or Med-Device or Regulatory experience
OR
Associate’s degree and 10 years of Health Agency or Med-Device or Regulatory experience
OR
High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience
 

Preferred Qualifications:

• MS Degree
• Degree in Regulatory Affairs, Life Sciences, or Engineering
• 6+ years experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations
• 8+ years of experience in software development, medical device, IVD, companion diagnostics, and/or combination product industry