Senior Regulatory Strategist, CDx/IVD & Global Submissions

Merck; Salt Lake City (UT); On-site; USD 250,000 - 360,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead regulatory strategy and oversight across global programs. This senior role partners with R&D, Biomarker Development, Translational Medicine, Statistics, and Regulatory Affairs to advance diagnostic products through global registration.

You will manage a team of regulatory professionals, guide complex programs, and interact with external partners and regulators to align on requirements and timelines.

Qualifications

• Senior regulatory leader with CDx/IVD experience.
• Experience leading global regulatory submissions for diagnostic products.
• Ability to influence senior leaders and collaborate across functions.

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products.
• Provide strategic and tactical regulatory guidance to product teams and senior leaders.
• Manage regulatory activities for development, registration, approval, and lifecycle management of CDx/IVD products.
• Offer regulatory leadership for complex programs or major components of high-priority programs.
• Assess regulatory impacts on development, clinical development, and global registration strategies.
• Review regulatory strategies to ensure scientific rigor, compliance, and alignment with objectives.
• Identify regulatory risks and develop pragmatic, compliant mitigation plans.
• Collaborate across geographies to resolve regulatory issues proactively.
• Communicate with multiple senior stakeholders about risks and mitigations.

Skills

CDx/IVD regulatory

Regulatory strategy

Cross-functional leadership

Global submissions

Job description

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead regulatory strategy and oversight across global programs. This senior role partners with R&D, Biomarker Development, Translational Medicine, Statistics, and Regulatory Affairs to advance diagnostic products through global registration.

You will manage a team of regulatory professionals, guide complex programs, and interact with external partners and regulators to align on requirements and timelines.