Senior Regulatory Leader, CDx/IVD Strategy & Submissions

Merck; Annapolis (MD); On-site; USD 250,000 - 360,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics/IVD to lead global regulatory strategies and oversight across development portfolios. You will collaborate with R&D, translational medicine, statistics, and external partners to align on regulatory requirements and ensure timely global registrations.

The role requires senior leadership, strategic judgment, and the ability to direct a team through complex regulatory challenges while engaging with senior

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products supporting the company’s development portfolio.
• Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders to support program planning and decision-making.
• Manage regulatory activities related to the development, registration, approval, and lifecycle management of companion diagnostics 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 that 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/IVD to lead global regulatory strategies and oversight across development portfolios. You will collaborate with R&D, translational medicine, statistics, and external partners to align on regulatory requirements and ensure timely global registrations.

The role requires senior leadership, strategic judgment, and the ability to direct a team through complex regulatory challenges while engaging with senior