Senior Regulatory Liaison, CDx/IVD Strategy & Submissions

Merck; Providence (RI); On-site; USD 230,000 - 300,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). The role leads regulatory strategy development across the portfolio and partners with R&D, clinical, and regulatory teams to support global registration of diagnostic products.

The incumbent will provide regulatory leadership for complex programs, assess regulatory risks, and manage a team of regulatory professionals to ensure timely and compliant submissions and lifecycle management.

Qualifications

• Senior regulatory leadership experience in CDx/IVD
• Regulatory strategy development and lifecycle management
• Cross-functional collaboration with R&D, clinical, and regulatory authorities

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other IVD products.
• Provide strategic regulatory guidance to product teams and senior leaders for planning and decision-making.
• Lead regulatory activities from development through submission and lifecycle management, including interactions with authorities.

Job description

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). The role leads regulatory strategy development across the portfolio and partners with R&D, clinical, and regulatory teams to support global registration of diagnostic products.

The incumbent will provide regulatory leadership for complex programs, assess regulatory risks, and manage a team of regulatory professionals to ensure timely and compliant submissions and lifecycle management.