Amgen is seeking a Companion Diagnostic Regulatory Affairs Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus.
This particular role will focus on collaborating with Amgen's China partner, BeiGene, to develop diagnostic regulatory strategies that enable successful marketing authorization of diagnostics and therapies for patients in China.
Additionally, the Regulatory Affairs Manager will support in establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDx's).
Responsibilities of the Regulatory Affairs, Manager include:
- Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
- Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities.
- Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners.
- Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE).
- In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.
- Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (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 CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed.
Master's degree and 2 years of Health Agency or Med-Device or Regulatory experience
Bachelor's degree and 4 years of Health Agency or Med-Device or Regulatory experience
Associate's 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 experiencePreferred Qualifications:
- MS Degree
- Degree in Regulatory Affairs, Life Sciences, or Engineering
- 6 plus years of experience in Regulatory Affairs, including China, United States and other international medical device and/or IVD/CDx regulations
- 8 plus years of experience in medical device and/or IVD/CDx industry
provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.Amgen
focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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.
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.