Diagnostic Regulatory Affairs Manager

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: April 1, 2025

Job Description:

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 mission to serve patients drives 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 ManagerWhat you will doLets do this. Lets 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 (CDxs).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 the department in regulatory document management activities.
• Maintain regulatory SharePoint site and document archive/intelligence database(s)What we expect of youWe 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 Masters degree and 3 years of Health Agency or Med-Device or Regulatory experience
  • Or Bachelors degree and 5 years of Health Agency or Med-Device or Regulatory experience
  • Or Associates 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 experiencePreferred 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 industryWhat you can expect of usAs 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 possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.
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Keywords: Initial Therapeutics, Inc., Washington DC , Diagnostic Regulatory Affairs Manager, Executive , Washington, DC