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Job Description

Position Overview

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.

Primary Responsibilities

+ Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products supporting the company's development portfolio.

+ Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders to support program planning and decision-making.

+ Manage regulatory activities related to the 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 for assigned products and ensure that plans are scientifically sound, compliant with applicable requirements, and aligned with broader development objectives.

+ Apply high-level scientific and regulatory judgment to complex, novel, or unprecedented issues.

+ Identify regulatory risks and develop pragmatic, scientifically informed approaches that maintain compliance while supporting program objectives and timelines.

+ Collaborate across organizational and geographic boundaries to facilitate the timely and proactive resolution of regulatory issues.

+ Communicate with and manage multiple senior stakeholders across Research and Development and other relevant functions, providing awareness of program risks, regulatory issues, and potential mitigation strategies.

+ Lead regulatory interactions with external diagnostic partners and support alignment on co-development requirements, responsibilities, timelines, and regulatory deliverables.

+ Oversee or contribute to the preparation, review, and approval of diagnostic regulatory submissions, including pre-submission materials, Investigational Device Exemption submissions, premarket approval applications, 510(k) submissions, and other applicable regulatory filings.

+ Lead or support interactions with regulatory authorities, including the preparation of briefing documents, development of meeting strategies, and participation in regulatory agency meetings.

+ Review and approve regulatory communications and materials intended for submission to, or discussion with, regulatory authorities.

+ Review and approve background packages and other regulatory materials to ensure clarity, accuracy, consistency, and comprehensive presentation of relevant issues.

+ Review labeling and manage labeling negotiations with regulatory authorities, as appropriate, to support compliant labeling consistent with the company's development objectives.

+ Partner with international colleagues and diagnostic partners to identify appropriate regulatory pathways and support global development and registration activities.

+ Participate in regulatory due diligence involving potential diagnostic partners, development agreements, licensing opportunities, and external products or technologies.

+ Support external scientific and regulatory engagement, as appropriate, including interactions with industry organizations, regulators, and other stakeholders.

+ Monitor relevant regulatory developments and contribute to regulatory policy and advocacy activities related to companion diagnostics and in vitro diagnostics.

+ Represent the company, as appropriate, in external initiatives and interactions with regulatory authorities.

Leadership and People Management Responsibilities

+ Lead and manage a team of regulatory professionals responsible for 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, to support the evolving portfolio and organizational responsibilities.

+ Provide technical and professional leadership to team members and support their development through coaching, mentoring, performance management, development planning, and career guidance.

+ Establish clear expectations and promote consistent, high-quality regulatory practices across the team.

+ Foster an inclusive and collaborative working environment that encourages scientific rigor, constructive challenge, accountability, and effective cross-functional partnership.

Education Requirements

Required:

+ 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.

Required Experience and Skills

+ 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 requiremen...

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