Diagnostic Regulatory Affairs Manager

Amgen SA; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading biotechnology company seeks a Companion Diagnostic Regulatory Affairs Manager to shape strategies for in vitro diagnostics. The role involves guiding regulatory submissions, collaborating with partners, and ensuring compliance with health authorities. This position requires experience in regulatory affairs and document management systems, particularly in the medical device or diagnostic sectors.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan with generous contributions

Flexible work models including remote arrangements

Discretionary annual bonus

Stock-based long-term incentives

Award-winning time-off plans

Qualifications

• Doctorate or Master’s degree with regulatory experience.
• In-depth knowledge of regulatory processes and document management.
• 6+ years experience in Regulatory Affairs preferred.

Responsibilities

• Provide strategic regulatory guidance for IVD/CDx.
• Develop regulatory strategies for product registrations.
• Lead interactions with diagnostic partners and regulatory agencies.

Skills

Regulatory document management

Strategic guidance

Clinical regulatory strategies

Collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

VeevaVault

Job description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will support 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).

Key responsibilities:

• Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning and 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 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, prepare for and conduct 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 and least burdensome regulatory paths toward development and global registration activities
• Assessing the impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development and 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
• Manage Regulatory Information Management System (e.g. VeevaVault) and support thedepartment in regulatory document management activities.
• Maintain regulatory SharePoint site and document archive/intelligence database(s)

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The versatile expert we are looking for plays a crucial role as a collaborative partner and possesses these credentials.

Basic Qualifications:

Must have in depth knowledge of regulatory document management systems including content management and archival, such as VeevaVault.

Doctorate degree

Or

Master’s degree and 3 years of Health Agency or Med-Device or Regulatory experience

Or

Bachelor’s degree and 5 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 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

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.

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.

careers.amgen.com

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.