The Executive Director of Regulatory Affairs, Companion Diagnostics (CDx) will be responsible for developing, advising on and executing global regulatory strategies for companion diagnostic products supporting development and approved products, ensuring compliance with regulatory agencies such as the FDA, EMA, and other health authorities. This role will provide leadership and direction to cross-functional teams involved in the co-development of diagnostics and drugs and will collaborate with diagnostic and pharmaceutical partners to streamline the regulatory approval processes. The individual will ensure the development of the global strategy for Health Authority interactions related to companion diagnostics. He/she will also provide line management, people development and performance management as well as support/ lead development and implementation of department policies.Key Responsibilities:Regulatory Strategy Development:
Lead the global regulatory strategy for companion diagnostics, ensuring alignment with therapeutic development and commercialization timelines.
Stay informed about evolving regulatory requirements, policies, and guidelines related to CDx, and proactively adapt strategies to meet new regulations.
Guide teams in the interpretation of regulatory requirements, providing strategic insights to integrate CDx with the company’s therapeutic programs.
Regulatory Submissions and Approvals:
Coordinate all regulatory submissions for companion diagnostics, including Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications, and other required filings with the FDA, EMA, and other global health authorities.
Oversee the preparation and submission of regulatory documents and responses, ensuring timely and accurate submissions that meet global regulatory requirements.
Act as the primary point of contact for regulatory bodies, managing relationships and communications to facilitate efficient reviews and approvals.
Cross-Functional Collaboration:
Work closely with Clinical Biomarker Science and CDx Development, Clinical Development, Research & Development, Commercial, and Legal teams to integrate regulatory requirements into the overall CDx development process.
Collaborate with external diagnostic and pharmaceutical partners to align on regulatory strategies and ensure consistent regulatory approaches across programs.
Support the integration of CDx into clinical trials, ensuring all regulatory aspects are addressed to enable timely initiation and execution.
Compliance and Risk Management:
Ensure all companion diagnostic products comply with applicable global regulatory requirements and standards (e.g., FDA, EMA, ISO, etc.).
Identify regulatory risks and provide mitigation strategies throughout the CDx product lifecycle.
Lead efforts to audit and maintain compliance with internal and external regulations, including leading responses to regulatory inspections and audits related to CDx.
Health Authority Engagement:
Develop and maintain productive relationships with regulatory agencies, representing the company in meetings, consultations, and negotiations.
Provide regulatory expertise to cross-functional teams, advising on regulatory interactions, inspections, and compliance-related matters for companion diagnostics.
Team Leadership and Development:
Lead, mentor, and develop a team of regulatory professionals focused on companion diagnostics, fostering a culture of regulatory excellence.
Ensure continuous development of the team’s regulatory expertise and professional growth in line with evolving industry standards.
Qualifications:
Bachelor’s, Master’s, or PhD in Life Sciences, Regulatory Affairs, or a related field. Regulatory Affairs Certification (RAC) or similar credential is a plus.
12+ years of regulatory experience in the life sciences industry, with at least 5 years focused on companion diagnostics or related diagnostic products.
Proven track record of managing regulatory submissions and approvals for diagnostic devices, ideally within the pharmaceutical industry or with drug-diagnostic co-development programs.
Deep understanding of regulatory guidelines and requirements for in vitro diagnostics (IVDs), medical devices, and companion diagnostics, particularly in the U.S. (FDA) and EU (EMA).
Experience with global regulatory health authorities, including successful submissions and interactions with agencies such as FDA, EMA, and PMDA.
Strong project management and organizational skills with the ability to manage multiple complex projects simultaneously.
Demonstrated leadership and team management skills with experience leading regulatory teams.
Preferred Skills:
In-depth knowledge of U.S. and international regulatory frameworks for diagnostics and medical devices.
Strong analytical skills with the ability to interpret regulatory guidelines and communicate complex regulatory concepts clearly.
Excellent verbal and written communication skills for interaction with health authorities and cross-functional teams.
Ability to influence and collaborate with diverse teams, including clinical, R&D, commercial, and legal professionals.
Travel Requirements:
International and domestic travel up to 20%, as required.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
