Companion Diagnostic/IVD Regulatory Senior Manager
Amgen is seeking a Companion Diagnostic Regulatory Affairs Lead, Senior Managerto 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 (CDxs).
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.
Doctorate degree and 2 years of Health Agency or Med-Device or Regulatory experience
Masters degree and 6 years of Health Agency or Med-Device or Regulatory experience
Bachelors degree and 8 years of Health Agency or Med-Device or Regulatory experience
Associates degree and 10 years of Health Agency or Med-Device or Regulatory experience
High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience
- 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/orcombination product industry
Join UsIf 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.