Senior Director, CDx/IVD Regulatory Strategy

Merck; Montpelier (VT); On-site; USD 250,000 - 350,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategy across diagnostic portfolios. You will partner with R&D, Clinical Research, Biomarker Development, and Regulatory Affairs to drive timely global registrations and lifecycle management.

You will guide external partners, manage a regulatory leadership team, and liaison with authorities to align requirements and development plans for complex diagnostic programs.

Qualifications

• Extensive regulatory leadership experience in CDx/IVD programs.
• Strong ability to translate complex scientific data into regulatory strategies.
• Experience collaborating with cross-functional teams and senior leadership.

Responsibilities

• Develop global regulatory strategies for companion diagnostics and IVD products.
• Provide regulatory guidance to product development teams and senior leaders.
• Oversee regulatory activities from development through lifecycle management of CDx/IVD products.
• Lead complex programs and manage regulatory risk with pragmatic strategies.
• Collaborate with international teams and diagnostic partners on regulatory pathways.
• Prepare, review, and approve regulatory submissions and communication with authorities.
• Engage with regulators in meetings and briefing documents and ensure compliant labeling.

Job description

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategy across diagnostic portfolios. You will partner with R&D, Clinical Research, Biomarker Development, and Regulatory Affairs to drive timely global registrations and lifecycle management.

You will guide external partners, manage a regulatory leadership team, and liaison with authorities to align requirements and development plans for complex diagnostic programs.