Senior CDx/IVD Regulatory Strategy Leader

Merck; Denver (CO); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies and interact with authorities and partners. The role requires guiding cross-functional teams and senior leadership through development, registration, and lifecycle management of diagnostic products.

The candidate will oversee regulatory submissions, assess risks, and stay ahead of evolving regulatory landscapes to ensure timely global registrations and program success.

Qualifications

• Must have extensive regulatory leadership experience in CDx/IVD.
• Experience with global regulatory submissions and lifecycle management.
• Ability to influence cross-functional teams and senior leaders.

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and IVDs.
• Provide strategic CDx/IVD regulatory guidance to product teams.
• Lead regulatory activities from development to submission and lifecycle.
• Manage regulatory interactions with authorities and partners.
• Identify regulatory risks and create mitigation plans.
• Collaborate across functions and geographies to align on requirements.
• Oversee preparation and review of regulatory submissions.
• Monitor regulatory developments and contribute to policy.

Skills

Regulatory leadership

CDx/IVD regulatory

Global regulatory strategies

Stakeholder communication

Team leadership

Regulatory submissions

Risk assessment

Job description

Merck is seeking an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies and interact with authorities and partners. The role requires guiding cross-functional teams and senior leadership through development, registration, and lifecycle management of diagnostic products.

The candidate will oversee regulatory submissions, assess risks, and stay ahead of evolving regulatory landscapes to ensure timely global registrations and program success.