[Hiring] Dist. Scientist, Regulatory Liaison @MSD

Role Description

The Executive Director, Regulatory Liaison, Companion Diagnostics/In Vitro Diagnostics (CDx/IVD), serves as 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.

This individual partners closely with colleagues across Research and Development, including Clinical Research, Biomarker Development, Translational Medicine, Statistics, Regulatory Affairs, and other relevant functions, to support the timely development and global registration of diagnostic products.

The Executive Director also works directly with external diagnostic partners and regulatory authorities to align on regulatory requirements and development strategies.

The Executive Director provides strategic leadership and oversight for assigned programs and manages a team of regulatory professionals supporting multiple projects. The role requires strong scientific and regulatory judgment, the ability to operate independently in complex and evolving areas, and the ability to communicate effectively with senior leaders and other internal and external stakeholders.

Qualifications

• 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.
• Acceptable advanced-degree combinations may include:
  • Master’s degree in a relevant discipline with a minimum of 10 years of relevant experience; or
  • Doctoral degree, such as a Ph.D., M.D., Pharm.D., or equivalent degree, with a minimum of 7 years of relevant experience.
• Relevant experience should include significant responsibility for diagnostic regulatory strategy, diagnostic product development, or the regulatory development of products involving companion diagnostics or other IVDs.

Requirements

• Significant regulatory experience in companion diagnostics and/or in vitro diagnostics.
• Demonstrated knowledge of diagnostic product development and the 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 matters.
• 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.
• Demonstrated 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 the ability to work independently while maintaining effective collaboration across functions.
• Demonstrated leadership attributes, including the ability to build relationships, influence decisions, manage conflict constructively, and develop regulatory professionals.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.