Director, Regulatory Affairs - In-Vitro Diagnostics (IVD)

Amgen • Thousand Oaks, CA

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Regulatory Affairs - In-Vitro Diagnostics (IVD) What you will do Let’s do this. Let’s change the world. Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks, CA location. The Regulatory Affairs division establishes sustainable processes, assures informed relationships, and delivers strategic outcomes. In this vital role, you will lead and manage the team responsible for developing and implementing optimal regulatory strategies and processes for in-vitro diagnostics (IVDs) and companion diagnostics (CDx). Key responsibilities will include:

Requirements

• Doctorate degree and 4 years of directly related experience OR Master’s degree and 7 years of directly related experience OR Bachelor’s degree and 9 years of directly related experience

Nice To Haves

• Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for products in differing stages of the product lifecycle
• Experience of leading and/or participating in meetings with regulators in major markets (US, EU, Japan and China)
• Knowledge of global CMC/Device regulations and understanding of evolving challenges and health authority expectations
• Track record as a strong coach and mentor

Responsibilities

• Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture of inclusion, diversity, and collaboration.
• Oversee resource allocation and operational strategies to effectively support the complex development pipelines.
• Develop regulatory positions, best practices, and SOPs to ensure efficient support for submissions and approvals.
• Lead cross-functional and global teams on regulatory issues, ensuring seamless communication and collaboration across all stakeholders.
• Lead the team to navigate IVD/CDx regulatory pathways, including the drug/diagnostics co-development process, clinical performance studies, analytical validations, and post-market compliance.
• Direct the team to develop and execute regulatory planning and submissions (e.g., PMA, 510(k), IDE) to achieve approvals across multiple regions, including the US, EU, Japan, and China.
• Collaborate with diagnostic partners on co-development programs, ensuring alignment and compliance.
• Utilize regulatory tools, such as databases and frameworks, for efficient content planning and reporting.
• Ensure the team’s adherence to regulations, guidance and international standards, including ISO 13485, ISO 14971, and CLSI guidelines.
• Design and implement global regulatory strategies that align with business goals and product development timelines.
• Anticipate and address regulatory challenges proactively through strong problem-solving skills.
• Evaluate the regulatory impact of new guidance, standards, and legislation on ongoing and future projects.
• Prepare and/or review comprehensive regulatory documentation, submissions, and presentations with exceptional written and verbal communication skills.
• Manage relationships with regulatory agencies, diagnostic partners, and internal stakeholders through strong negotiation and influencing skills.
• Clearly articulate complex regulatory requirements and strategies to non-regulatory audiences, fostering alignment and understanding.
• Represent the organization in external working groups, forums, or standards organizations (e.g., PhRMA, BIO, AAMI, ISO).
• Demonstrate adaptability and resilience under pressure, maintaining a focus on achieving results.
• Effectively prioritize and manage multiple projects and deadlines through strong organizational skills.

Benefits

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
• From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees