Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Biosystems, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems, were not just shaping the future of cancer diagnostics were transforming lives. Our mission of Advancing Cancer Diagnostics, Improving Lives is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, youll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Senior Director, Regulatory Affairs CDx Biopharma is responsible for shaping and executing regulatory strategies that enable accelerated growth in the U.S. CDx Pharma business. This position is a strategic enabler across enterprise systemsworking alongside the CDX business development team to drive complex partnership CDx, Pharma product development (NPD) launches, market expansion, and partner success.

As precision medicine and AI-driven diagnostics redefine the landscape, this leader will proactively manage regulatory complexity, ensuring alignment with commercial timelines, partner expectations, and global strategies. The role requires close collaboration with the U.S.-based CDx Business Development team and pharmaceutical partners to deliver FDA-focused submission strategies for co-developed CDx products linked to drug approvals

This position reports to the SVP, Global Regulatory and Clinical Affairs and is part of the Regulatory and Clinical team located in Deer Park, IL and will be a remote role.

In this role, you will have the opportunity to:

Global Regulatory Strategy & Submissions: Leads development and execution of comprehensive global regulatory strategy for CDx, Pharma, and AI-enabled assay products, ensuring submission planning is fully integrated with commercial timelines and partner expectations. Maintains global oversight while prioritizing U.S. regulatory pathways to enable first-to-market launches, embedding regulatory strategy into enterprise systems to accelerate approvals and new product development launches while proactively managing risk and evolving regulatory standards.

Regulatory Authority Engagement & Regulatory Intelligence: Drives real-time engagement with regulatory authorities via meetings and rapid response to queries, building strong relationships to support co-developed CDx products linked to drug approvals. Maintains global regulatory intelligence processes across IVD, CDx, SaMD, and precision medicine, preparing and communicating risk assessments and mitigation strategies to senior leadership.

Policy Influence & Global Regulatory Operations: Shapes regulatory policy and guidance through active participation in industry forums, advisory committees, and consultations with global health authorities, representing the organization externally. Ensures efficient global regulatory processes exist including impact assessments, country-specific submissions, and registration sustainment providing strategic interpretation of local requirements and their implications for product strategies.

Organizational Leadership & Talent Development: Makes high-impact organizational decisions grounded in deep industry expertise, ensuring the infrastructure, competencies, and resources are in place to meet global regulatory expectations. Leads experienced professionals, drives succession planning for critical roles, and builds high-caliber regulatory teams to staff cross-functional projects with qualified associates who deliver credible regulatory inputs and strategies.

Performance, Compliance & Continuous Improvement: Owns KPIs and performance metrics that drive business results and continuous improvement, serving as a leader in Danaher Business System (DBS) tools to enhance operational efficiency. Ensures teams are effective in Daily Management practices and takes proactive countermeasures when resourcing gaps arise to protect production, compliance, and business continuity.

As precision medicine and AI-driven diagnostics redefine the landscape, this leader will proactively manage regulatory complexity, ensuring alignment with commercial timelines, partner expectations, and global strategies. The role requires close collaboration with the U.S.-based CDx Business Development team and pharmaceutical partners to deliver FDA-focused submission strategies for co-developed CDx products linked to drug approvals

The essential requirements of the job include
Advanced degree in a relevant Scientific background
10+ years leadership experience in regulatory affairs within the CDx and Pharma industry, including high-complexity technologies such as AI-enabled assays.
Extensive experience leading complex, cross-functional programs with full accountability for timelines, budgets, and deliverables.
Proven success in developing and executing global regulatory strategies that enable timely product development in collaboration with the FDA and Pharma Partners. Navigating complex regulatory landscapes and building strong relationships with regulatory authorities.
Strong track record of leading global regulatory submissions and product registrations
Demonstrated ability to lead and develop high-performing regulatory teams in aglobal, matrixed environment.
Experienced in applying tools to drive continuous improvement, operational efficiency, and regulatory readiness.

Travel Requirements:
The need to travel may be significant at times (approximately 30% overnight travel)

Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range OR the hourly range for this role is $200,000 - $270,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.