Distinguished Scientist, Regulatory Liaison

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Develop and manage global regulatory strategies for companion diagnostics and various in vitro diagnostic products.

• Offer strategic and tactical regulatory guidance related to CDx/IVD to product development teams, regulatory liaisons, and senior management.

• Oversee regulatory activities concerning the development, registration, approval, and lifecycle management of companion diagnostics and other IVD products.

• Provide regulatory leadership for complex programs or significant components of high-priority initiatives.

• Evaluate the implications of diagnostic and drug regulations on diagnostic development, clinical progression, and global registration strategies.

• Review regulatory strategies to ensure that they are scientifically valid, compliant, and in harmony with development goals.

• Identify regulatory risks and create practical approaches that support compliance, objectives, and timelines.

• Collaborate across organizational and geographical boundaries to address regulatory challenges.

• Manage senior stakeholders and communicate program risks, regulatory concerns, and mitigation strategies.

• Lead regulatory discussions with external diagnostic partners.

• Oversee or assist with diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, pre-submission materials, and other filings.

• Lead or assist in interactions with regulatory authorities, including preparing briefing documents, meeting strategies, and participating in agency meetings.

• Review and approve regulatory communications, background packages, and submission materials.

• Review labeling and oversee negotiations with regulatory authorities regarding labeling.

• Support global development and registration efforts with international colleagues and diagnostic partners.

• Participate in regulatory due diligence activities involving partners, development agreements, licensing opportunities, and external products or technologies.

• Assist with external scientific and regulatory engagement, policy, and advocacy initiatives.

• Monitor regulatory changes and represent the company in external initiatives and interactions with regulatory authorities.

• Lead and manage a team of regulatory professionals.

• Assign regulatory liaisons, manage resources and priorities, recruit and onboard new staff, and provide coaching, mentoring, performance management, development planning, and career guidance.

• Establish expectations and promote consistent regulatory practices.

• Cultivate an inclusive and collaborative environment that encourages scientific rigor, accountability, and cross-functional partnerships.

⛳️ Requirements

• Bachelor’s degree in biological science, chemistry, engineering, regulatory science, or a related field with at least 12 years of relevant drug-development or regulatory experience, including substantial regulatory affairs background; or a master’s degree with a minimum of 10 years of relevant experience; or a doctoral degree with at least 7 years of relevant experience.

• Extensive regulatory experience in companion diagnostics and/or in vitro diagnostics.

• Strong understanding of diagnostic product development and the regulatory requirements pertinent to companion diagnostics and IVDs.

• Proven experience in developing regulatory strategies and supporting regulatory submissions for diagnostic products.

• Familiarity with interactions involving the U.S. Food and Drug Administration or other regulatory authorities.

• Robust scientific knowledge, professional credibility, and understanding of regulatory requirements across relevant global markets.

• Capacity to interpret evolving regulatory requirements and apply them to complex development programs.

• Ability to devise innovative and practical regulatory strategies for complicated or unprecedented issues.

• Experience in leading high-performing teams or projects while managing multiple priorities in a matrixed environment.

• Proficient in communicating complex scientific and regulatory matters clearly and effectively to senior leaders, development teams, diagnostic partners, and regulatory authorities.

• Exceptional written, verbal, interpersonal, negotiation, and presentation skills.

• Strong organizational abilities, sound judgment, and the capacity to work independently while fostering effective collaboration across functions.

• Proven leadership qualities, including relationship building, influencing decisions, constructive conflict management, and developing regulatory professionals.

• No visa sponsorship available.

🏝️ Benefits

• Annual bonus and potential long-term incentives, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave and sick days.

• Remote work arrangements.