Global CDx/IVD Regulatory Strategy Director

Merck; Rahway (NJ); On-site; USD 250,000 - 350,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). The role leads regulatory strategy development, partners with R&D teams, and directs global regulatory activities to support timely registration of diagnostic products.

The leader will guide cross-functional teams, manage regulatory submissions, and collaborate with external partners and regulators to align pathways and deliverables in a fast-paced environment.

Responsibilities

• Develop global regulatory strategies for CDx/IVD products.
• Provide regulatory guidance to development teams and senior leaders.
• Manage regulatory activities for development, registration, and lifecycle management.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Job description

Merck in Rahway, NJ is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). The role leads regulatory strategy development, partners with R&D teams, and directs global regulatory activities to support timely registration of diagnostic products.

The leader will guide cross-functional teams, manage regulatory submissions, and collaborate with external partners and regulators to align pathways and deliverables in a fast-paced environment.