Senior Director, CDx/IVD Regulatory Strategy

Merck; United States; On-site; USD 260,000 - 380,000; Full time

Job summary

Merck in the United States seeks an Executive Director of Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics. This senior leader will shape global regulatory strategies, coordinating with R&D, Clinical Research, Biomarker Development, and Regulatory Affairs to drive timely regulatory registrations and lifecycle management across programs.

The role requires strong scientific and regulatory judgment, independence in complex environments, and the ability to communicate with

Qualifications

• Senior regulatory leadership experience in CDx/IVD programs.
• Proven ability to develop global regulatory strategies across development portfolios.
• Strong cross-functional collaboration with R&D, Clinical, Biomarker Development and Regulatory Affairs.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide regulatory guidance to product teams and senior leaders.
• Manage regulatory activities from development through lifecycle management.

Skills

Regulatory strategy

CDx/IVD regulatory

Leadership

Stakeholder management

Education

PhD in life sciences

Tools

Regulatory submissions systems

Job description

Merck in the United States seeks an Executive Director of Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics. This senior leader will shape global regulatory strategies, coordinating with R&D, Clinical Research, Biomarker Development, and Regulatory Affairs to drive timely regulatory registrations and lifecycle management across programs.

The role requires strong scientific and regulatory judgment, independence in complex environments, and the ability to communicate with