Executive Director, Regulatory Strategy - CDx/IVD

Merck; Lincoln (NE); On-site; USD 180,000 - 260,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will develop and oversee global regulatory strategies, partnering with R&D colleagues across Clinical Research, Biomarker Development, Translational Medicine, Statistics, and Regulatory Affairs to support timely global registration of diagnostic products.

The role also governs interactions with external partners and regulators, guiding submissions

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products.
• Provide strategic and tactical CDx/IVD regulatory guidance to development teams, regulatory liaisons, and senior leaders.
• Manage regulatory activities related to development, registration, approval, and lifecycle management of CDx and other IVD products.
• Provide regulatory leadership for complex programs or major components of high-priority programs.
• Assess the impact of diagnostic and drug regulations on diagnostic development, clinical development, and global registration strategies.
• Review regulatory strategies for assigned products and ensure plans are scientifically sound, compliant with applicable requirements, and aligned with broader development objectives.
• Apply high-level scientific and regulatory judgment to complex, novel, or unprecedented issues.
• Identify regulatory risks and develop pragmatic, scientifically informed approaches that maintain compliance while supporting program objectives and timelines.
• Collaborate across organizational and geographic boundaries to facilitate the timely and proactive resolution of regulatory issues.
• Communicate with and manage multiple senior stakeholders across Research and Development and other relevant functions, providing awareness of program risks, regulatory issues, and potential mitigation strategies.
• Lead regulatory interactions with external diagnostic partners and support alignment on co-development requirements, responsibilities, timelines, and regulatory deliverables.
• Oversee or contribute to the preparation, review, and approval of diagnostic regulatory submissions, including pre-submission materials, Investigational Device Exemption submissions, premarket approval applications, 510(k) submissions, and other applicable regulatory filings.
• Lead or support interactions with regulatory authorities, including the preparation of briefing documents, development of meeting strategies, and participation in regulatory agency meetings.
• Review and approve regulatory communications and materials intended for submission to, or discussion with, regulatory authorities.
• Review and approve background packages and other regulatory materials to ensure clarity, accuracy, consistency, and comprehensive presentation of relevant issues.
• Review labeling and manage labeling negotiations with regulatory authorities, as appropriate, to support compliant labeling consistent with the company’s development objectives.
• Partner with international colleagues and diagnostic partners to identify appropriate regulatory pathways and support global development and registration activities.
• Participate in regulatory due diligence involving potential diagnostic partners, development agreements, licensing opportunities, and external products or technologies.
• Support external scientific and regulatory engagement, as appropriate, including interactions with industry organizations, regulators, and other stakeholders.
• Monitor relevant regulatory developments and contribute to regulatory policy and advocacy activities related to companion diagnostics and in vitro diagnostics.
• Represent the company, as appropriate, in external initiatives and interactions with regulatory authorities.

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will develop and oversee global regulatory strategies, partnering with R&D colleagues across Clinical Research, Biomarker Development, Translational Medicine, Statistics, and Regulatory Affairs to support timely global registration of diagnostic products.

The role also governs interactions with external partners and regulators, guiding submissions