Companion Diagnostic Regulatory Affairs Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Companion Diagnostic Regulatory Affairs Manager

What you will do

Lets do this. Lets change the world. In this vital role you 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 (CDxs).

• 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 implementing 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.

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.

Doctorate degree

Masters degree and 3 years of Health Agency or Med-Device or Regulatory experience

Bachelors degree and 5 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 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations
• 8 plus years of experience in medical device and/or IVD/CDx industry

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.

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

for a career that defies imagination

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

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.