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About the Role
Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer through the development of life-improving therapies and ensuring global access. As a people leader, you will be key in evolving our culture and creating an inclusive, developed, and empowered environment for employees to achieve their aspirations.
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.
Requirements
- 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 participate in global meetings, communicate with international stakeholders, and review regulatory submissions and correspondence.
- Strong written and verbal communication skills in both Japanese and English.
Skills
- Regulatory Affairs
- Regulatory strategy
- Regulatory dossier preparation
- ICH guidelines
- Japan-specific regulatory requirements
- Clinical study regulatory activities
- Cartagena Act compliance
- Marketing applications
- Change applications
- Change notifications
- GCTP compliance
- Health authority interactions
- Risk assessment
- Regulatory issue management
- Cross-functional collaboration
- Industry association participation
Location
- Santa Monica, CA
Work Type
- Full-time
Experience Level
- 8+ years
Education Level
- Advanced degrees or certifications, including a PhD or MS, are preferred.
- Bachelor’s degree
About the Company
- Kite Pharma offers the opportunity to be part of a successful, fast-growing company in a cross functional and collaborative environment.
- Visit our website at www.kitepharma.com
- Follow @Kite Pharma on Twitter at www.twitter.com/kitepharma
Equal Opportunity
- Kite Pharma, an equal opportunity employer.