Global CDx/IVD Regulatory Strategy Lead

Merck; Madison (WI); On-site; USD 260,000 - 360,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will shape global strategies, guide cross-functional teams, and collaborate with external partners and authorities to advance diagnostic development and registration.

The role demands strategic judgment, independent operation in complex areas, and effective communication with senior stakeholders across R&D and regulatory functions.

Qualifications

• The candidate has senior regulatory leadership experience in companion diagnostics or in vitro diagnostics products.
• Ability to develop global regulatory strategies aligning with development portfolios.
• Strong scientific and regulatory judgment with experience guiding cross-functional teams.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to product teams and senior leaders.
• Lead regulatory activities from development to lifecycle management of CDx/IVD products.
• Assess regulatory risks and ensure compliant, timely program execution.
• Collaborate across functions and with external partners and authorities.

Skills

Regulatory leadership

CDx/IVD regulatory strategy

Cross-functional collaboration

Stakeholder communication

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will shape global strategies, guide cross-functional teams, and collaborate with external partners and authorities to advance diagnostic development and registration.

The role demands strategic judgment, independent operation in complex areas, and effective communication with senior stakeholders across R&D and regulatory functions.