Manager, Kite Regulatory Affairs CMC

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About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   Specific Job Responsibilities: • Lead and support Japan regulatory strategy and execution for cell and gene therapy products across development and post-approval stages. • Prepare, review, and maintain high-quality regulatory dossiers in accordance with ICH guidelines and Japan-specific requirements. • Lead and support Japan-specific regulatory activities required prior to initiation of clinical studies, including regulatory consultations with health authorities on quality and safety matters. • Support regulatory activities related to compliance with the Cartagena Act and other applicable Japan-specific requirements for cell and gene therapy products. • Lead and support marketing applications, partial change applications, and minor change notifications in Japan. • Lead and support GCTP compliance inspection applications, serving as a key liaison with global stakeholders, including overseas manufacturing sites, to facilitate document collection, application preparation, and responses to regulatory inquiries. • Build and maintain effective working relationships with PMDA and other relevant health authorities, representing the company in a professional and constructive manner. • Ensure timely and aligned communications with health authorities regarding regulatory questions and responses, in close collaboration with global and regional colleagues. • Conduct risk assessments on major regulatory issues impacting Japan submissions and product lifecycle management. • Stay current on evolving Japan regulatory requirements, guidance, and best practices for cell and gene therapy products, and communicate relevant updates to internal stakeholders in a timely manner. • Assist in preparing briefing packages and background materials for health authority meetings and contribute to the development of regulatory strategies. • Lead or contribute to ad hoc cross-functional task forces to address critical regulatory issues. • Participate, as appropriate, in industry associations and professional networks to maintain awareness of regulatory trends and emerging best practices. Qualifications: • Advanced degrees or certifications, including a PhD or MS, are preferred. • Relevant industry experience is preferred. • A minimum of 8 years of experience in Regulatory Affairs, or relevant industry experience following a bachelor’s degree, is required. • Native-level Japanese proficiency. Ability to communicate highly technical and regulatory concepts in Japanese, including interactions with PMDA and preparation/review of regulatory submissions. • Business-level English, including the ability to pa

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