Senior Director, Global Regulatory Affairs, Pharmaceutical Partner and CDx

Danaher•Deer Park, TX

4d•Remote

About The Position

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 Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re 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, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll 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, you’ll 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 systems—working 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. 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

Requirements

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 a global, matrixed environment.
Experienced in applying tools to drive continuous improvement, operational efficiency, and regulatory readiness.
The need to travel may be significant at times (approximately 30% overnight travel)

Responsibilities

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.

Benefits

Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume