Senior CDx/IVD Regulatory Strategy Lead

Merck; Atlanta (GA); On-site; USD 200,000 - 260,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). This senior leader will develop global regulatory strategies, guide development teams, and oversee lifecycle management across multiple projects.

The role requires influencing senior stakeholders and coordinating with regulatory authorities worldwide. The position leads a team of regulatory professionals, partners with R&D colleagues, and drives strategic and tactical planning to

Qualifications

• Strong scientific and regulatory judgment.
• Experience leading regulatory strategies for global CDx/IVD programs.
• Ability to influence senior leaders and external stakeholders.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide regulatory guidance to product teams and senior leaders.
• Lead regulatory activities across development, submission, and lifecycle management.
• Provide leadership for complex programs and high-priority components.
• Assess regulatory risks and develop compliant, timely approaches.
• Collaborate跨 organizational and geographic boundaries to resolve issues.
• Lead regulatory interactions with external diagnostic partners and authorities.
• Oversee preparation and review of regulatory submissions and filings.
• Support regulatory agency meetings and briefing materials.
• Review labeling and deliverables for compliance.
• Engage with international colleagues to align on pathways.
• Participate in regulatory due diligence and external partnerships.

Skills

Regulatory leadership

CDx/IVD regs

Regulatory submissions

Stakeholder communication

Team leadership

Regulatory authorities

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/In Vitro Diagnostics (CDx/IVD). This senior leader will develop global regulatory strategies, guide development teams, and oversee lifecycle management across multiple projects.

The role requires influencing senior stakeholders and coordinating with regulatory authorities worldwide. The position leads a team of regulatory professionals, partners with R&D colleagues, and drives strategic and tactical planning to