Dist. Scientist, Regulatory Liaison

MSD•Rockville, MD

1d•$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 with Research and Development functions and external diagnostic partners and regulatory authorities to support diagnostic development and global registration. The Executive Director provides strategic leadership and oversight for assigned programs, manages a team of regulatory professionals, and applies scientific and regulatory judgment to complex and evolving issues. The position includes responsibility for regulatory strategy, submissions, agency interactions, labeling, regulatory risk management, and cross-functional alignment, as well as team leadership, staff development, and resource management. The role is remote, has a primary location in Rockville, Maryland, and requires 10% travel. The listed shift is 1st - Day. The role is a regular employee position with no relocation offered.

Requirements

Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or 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 a Ph.D., M.D., or Pharm.D. with at least 7 years of relevant experience.
Relevant experience must include significant responsibility for diagnostic regulatory strategy, diagnostic product development, or regulatory development involving companion diagnostics or other IVDs.
Significant regulatory experience in companion diagnostics and/or in vitro diagnostics.
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.
Demonstrated 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, 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 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 a biological science, chemistry, engineering, regulatory science, medicine, pharmacy, or 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.
Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders.
Manage regulatory activities related to diagnostic development, registration, approval, and lifecycle management.
Provide regulatory leadership for complex programs and major components of high-priority programs.
Assess the impact of diagnostic and drug regulations on diagnostic development, clinical development, and global registration strategies.
Review product 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, scientifically informed approaches.
Collaborate across organizational and geographic boundaries to resolve regulatory issues proactively and in a timely manner.
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 preparation, review, and approval of diagnostic regulatory submissions, including pre-submission materials, IDEs, PMAs, 510(k)s, and other filings.
Lead or support regulatory-authority interactions, including briefing documents, meeting strategies, and 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.
Partner with international colleagues and diagnostic partners to identify regulatory pathways and support global development and registration.
Participate in regulatory due diligence related to diagnostic partners, development agreements, licensing opportunities, external products, or technologies.
Support external scientific and regulatory engagement, including interactions with industry organizations, regulators, and other stakeholders.
Monitor regulatory developments and contribute to regulatory policy and advocacy for companion diagnostics and IVDs.
Represent the company in external initiatives and interactions with regulatory authorities, 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 qualified staff as needed.
Provide technical and professional leadership through coaching, mentoring, performance management, development planning, and career guidance.
Establish clear expectations and promote consistent, high-quality regulatory practices.
Foster an inclusive, collaborative environment that supports scientific rigor, constructive challenge, accountability, and cross-functional partnership.