Companion Diagnostic/IVD Regulatory Senior Manager

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Companion Diagnostic/IVD Regulatory Senior Manager

Live

What you will do

Lets do this. Lets change the world. 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. In this vital role you will develop and implement regulatory strategies and processes for in-vitro diagnostics (IVDs)/companion diagnostics (CDxs). Key responsibilities will include:

• Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making globally, concentrating on US, EU, Japan, and China.
• 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Health Agency, Medical Device or Regulatory experience

Or

Masters degree and 6 years of Health Agency, Medical Device or Regulatory experience

Or

Bachelors degree and 8 years of Health Agency, Medical Device or Regulatory experience

Or

Associates degree and 10 years of Health Agency, Medical Device or Regulatory experience

Or

High school diploma / GED and 12 years of Health Agency, Medical 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $134,434 - $160,854.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Join Us

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 cancers, 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.