Executive Director, Global Regulatory Affairs Companion Diagnostics

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 submiss