Distinguished Scientist, Regulatory Liaison

MSD

. Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products .

Posted 11/9/2026full-timeRemote • United StatesSeniorLead💰 $231,900 - $365,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in developing and overseeing regulatory strategies for companion diagnostics and in vitro diagnostic products, with a strong focus on compliance, risk assessment, and stakeholder communication. Proven ability to lead teams and manage complex regulatory submissions while fostering collaboration across functions.

Highest-signal resume keywords

Regulatory Strategy DevelopmentCompanion Diagnostics ExperienceRegulatory Submissions ManagementLeadership in Regulatory AffairsStakeholder Communication

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsDiagnostic Product DevelopmentRegulatory SubmissionsIDE ManagementPMA Management510(k) ManagementRegulatory ComplianceRisk AssessmentGlobal Registration StrategiesRegulatory Requirements Interpretation

Soft Skills

Interpersonal SkillsNegotiation SkillsPresentation SkillsOrganizational SkillsConflict Management

Industry Keywords

In Vitro DiagnosticsCompanion DiagnosticsFDA InteractionRegulatory GuidanceClinical DevelopmentLifecycle ManagementGlobal MarketsRegulatory AuthoritiesScientific RigorCross-Functional Collaboration

About the role

Key responsibilities & impact

Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products
Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders
Manage regulatory activities related to 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 and ensure plans are scientifically sound, compliant, and aligned with development objectives
Identify regulatory risks and develop pragmatic approaches supporting compliance, objectives, and timelines
Collaborate across organizational and geographic boundaries to resolve regulatory issues
Manage senior stakeholders and communicate program risks, regulatory issues, and mitigation strategies
Lead regulatory interactions with external diagnostic partners
Oversee or contribute to diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, pre-submission materials, and other filings
Lead or support interactions with regulatory authorities, including briefing documents, meeting strategies, and agency meetings
Review and approve regulatory communications, background packages, and submission materials
Review labeling and manage labeling negotiations with regulatory authorities
Support global development and registration activities with international colleagues and diagnostic partners
Participate in regulatory due diligence involving partners, development agreements, licensing opportunities, and external products or technologies
Support external scientific and regulatory engagement, policy, and advocacy activities
Monitor regulatory developments and represent the company in external initiatives and regulatory-authority interactions
Lead and manage a team of regulatory professionals
Assign regulatory liaisons, manage resources and priorities, recruit and onboard staff, and provide coaching, mentoring, performance management, development planning, and career guidance
Establish expectations and promote consistent regulatory practices
Foster an inclusive, collaborative environment promoting scientific rigor, accountability, and cross-functional partnership

Requirements

What you’ll need

Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline, with a minimum of 12 years of relevant drug-development or regulatory experience, including substantial experience in regulatory affairs; or master’s degree with a minimum of 10 years of relevant experience; or doctoral degree with a minimum of 7 years of relevant experience
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
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 maintaining effective collaboration across functions
Demonstrated leadership attributes, including relationship building, influencing decisions, constructive conflict management, and developing regulatory professionals
No visa sponsorship

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Remote work arrangement