Dist. Scientist, Regulatory Liaison

Merck • Rockville, MD

17h • $231,900 - $365,000 • Remote

About The Position

The Executive Director, Regulatory Liaison, Companion Diagnostics/In Vitro Diagnostics (CDx/IVD), is a senior regulatory leader and subject matter expert responsible for developing and overseeing regulatory strategies for companion diagnostics and other in vitro diagnostic products supporting the company’s development portfolio. The role partners across Research and Development—including Clinical Research, Biomarker Development, Translational Medicine, Statistics, and Regulatory Affairs—and works with external diagnostic partners and regulatory authorities to support timely diagnostic development and global registration.

The position provides strategic leadership and oversight for assigned programs and manages a team of regulatory professionals supporting multiple projects. It calls for strong scientific and regulatory judgment, independent leadership in complex and evolving areas, and effective communication with senior leaders and internal and external stakeholders. The role is remote, with 10% travel, and is listed as a regular position with a day shift.

Requirements

• Bachelor’s degree in biological science, chemistry, engineering, regulatory science, or a related discipline, with at least 12 years of relevant drug-development or regulatory experience, including substantial regulatory affairs experience; alternatively, a relevant master’s degree with at least 10 years of relevant experience, or a doctoral degree (such as Ph.D., M.D., Pharm.D., or equivalent) with at least 7 years of relevant experience.
• Relevant experience must include significant responsibility for diagnostic regulatory strategy, diagnostic product development, or regulatory development of products involving companion diagnostics or other IVDs.
• Significant regulatory experience in companion diagnostics and/or in vitro diagnostics.
• Demonstrated knowledge of diagnostic product development and regulatory requirements applicable to companion diagnostics and IVDs.
• Experience developing regulatory strategies and supporting regulatory submissions for diagnostic products.
• Experience interacting with the U.S. Food and Drug Administration or other regulatory authorities on diagnostic development and registration.
• Strong scientific knowledge, professional credibility, and familiarity with regulatory requirements across relevant global markets.
• Ability to interpret evolving regulatory requirements and apply them to complex development programs.
• Ability to develop creative and pragmatic regulatory strategies for complex or unprecedented issues.
• Experience leading high-performing teams or projects and managing multiple priorities in a matrixed environment.
• Ability to communicate complex scientific and regulatory issues clearly and effectively to senior leaders, development teams, diagnostic partners, and regulatory authorities.
• Outstanding written, verbal, interpersonal, negotiation, and presentation skills.
• Strong organizational skills, sound judgment, and ability to work independently while collaborating effectively across functions.
• Leadership skills including relationship building, influencing decisions, constructive conflict management, and developing regulatory professionals.

Nice To Haves

• Advanced degree in biological science, chemistry, engineering, regulatory science, medicine, pharmacy, or a related discipline.
• Experience supporting global development and registration of companion diagnostic or IVD products.
• Experience with diagnostic co-development partnerships and associated regulatory agreements, responsibilities, and deliverables.
• Experience with diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, or comparable submissions outside the United States.
• Experience supporting regulatory due diligence, business-development transactions, or licensing activities involving diagnostic products or technologies.
• Knowledge of evolving regulatory policies and expectations affecting companion diagnostics, IVDs, biomarker-driven drug development, and precision medicine.

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products in the development portfolio.
• Provide strategic and tactical CDx/IVD regulatory guidance to development teams, regulatory liaisons, and senior leaders.
• Manage regulatory activities for diagnostic development, registration, approval, and lifecycle management.
• Lead regulatory work for complex programs or major components of high-priority programs.
• Assess how diagnostic and drug regulations affect diagnostic development, clinical development, and global registration strategies.
• Review regulatory strategies to ensure they are scientifically sound, compliant, and aligned with development objectives.
• Apply scientific and regulatory judgment to complex, novel, or unprecedented issues; identify risks and develop pragmatic, compliant approaches that support program objectives and timelines.
• Collaborate across organizational and geographic boundaries to resolve regulatory issues proactively and promptly.
• Communicate program risks, regulatory issues, and mitigation strategies to senior stakeholders across Research and Development and other functions.
• Lead regulatory interactions with external diagnostic partners and align co-development requirements, responsibilities, timelines, and deliverables.
• Oversee or contribute to diagnostic regulatory submissions, including pre-submission materials, IDE submissions, PMA applications, 510(k) submissions, and other applicable filings.
• Lead or support regulatory-authority interactions, including briefing documents, meeting strategies, and participation in agency meetings.
• Review and approve regulatory communications and materials for submission to or discussion with regulatory authorities.
• Review and approve background packages and other regulatory materials for clarity, accuracy, consistency, and completeness.
• Review labeling and manage labeling negotiations with regulatory authorities as appropriate.
• Work with international colleagues and diagnostic partners to identify regulatory pathways and support global development and registration.
• Participate in regulatory due diligence for diagnostic partnerships, development agreements, licensing opportunities, and external products or technologies.
• Support external scientific and regulatory engagement, including with industry organizations, regulators, and other stakeholders.
• Monitor regulatory developments and contribute to policy and advocacy activities related to companion diagnostics and IVDs; represent the company in external initiatives and regulatory-authority interactions as appropriate.
• Lead and manage a team of regulatory professionals supporting diagnostic programs across the development portfolio.
• Assign regulatory liaisons to projects and manage resources and priorities across programs.
• Recruit and onboard staff as needed.
• Coach, mentor, and support team members through performance management, development planning, and career guidance.
• Set clear expectations and promote consistent, high-quality regulatory practices.
• Foster an inclusive, collaborative environment that encourages scientific rigor, constructive challenge, accountability, and effective cross-functional partnership.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and families
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Annual bonus and long-term incentive, if applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Executive