Responsibilities:
Strategic Leadership Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization. Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements. Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks. Assess and communicate potential regulatory risks and propose mitigation plans.
Regulatory Submissions & Compliance Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs, and other relevant submissions to regulatory agencies. Lead strategy for global expedited pathways (e.g. RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US and EU), where applicable. Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing.
Regulatory Interactions Build and maintain strong relationships with FDA CBER and other regulatory agencies and represent the company in key regulatory meetings and negotiations. Ensure timely and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice.
Team Leadership Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy. Foster a culture of compliance, innovation, and continuous improvement. Coach team members on technical skills and leadership behaviors.
Qualifications: