Executive Director, Regulatory Strategy — CDx/IVD

Merck; Frankfort (KY); On-site; USD 250,000 - 500,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD) to serve as a senior regulatory leader responsible for developing and overseeing regulatory strategies for diagnostic products across the development portfolio.

This role partners closely with R&D, Regulatory Affairs, and external partners to support timely global registration and to align on regulatory requirements and development strategies.

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products for the development portfolio.
• Provide regulatory guidance to product development teams and senior leaders to support planning and decision-making.
• Oversee regulatory activities related to development, registration, approval, and lifecycle management of CDx/IVD products.
• Provide regulatory leadership for complex programs or major components of high-priority programs.
• Assess impact of diagnostic and drug regulations on development and global registration strategies.
• Review regulatory strategies to ensure scientific soundness and alignment with development objectives.
• Identify regulatory risks and develop pragmatic, compliant mitigation strategies.
• Collaborate across organizations and geographies to resolve regulatory issues in a timely manner.
• Communicate with multiple senior stakeholders on risks, issues, and mitigation strategies.
• Lead regulatory interactions with external diagnostic partners and align on co-development requirements and timelines.
• Oversee or contribute to regulatory submissions (pre-submissions, 510(k), PMA, IDE as applicable).
• Lead or support regulatory meetings with authorities, including briefing materials and meeting strategies.
• Review and approve regulatory communications and background packages for submissions.
• Review labeling and negotiations with authorities to support compliant labeling.
• Partner with international colleagues and diagnostic partners for global development and registration.
• Support regulatory due diligence for potential partners and external products.

Job description

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD) to serve as a senior regulatory leader responsible for developing and overseeing regulatory strategies for diagnostic products across the development portfolio.

This role partners closely with R&D, Regulatory Affairs, and external partners to support timely global registration and to align on regulatory requirements and development strategies.