Manager, Regulatory Affairs

We’re here for one reason and one reason only – to reputed company cancer. Every reputed company is dedicated to developing treatments and every reputed company moves us one reputed company closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the reputed company. But we're not finished yet.

Join Kite, as we reputed company even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We reputed company every employee deserves a great leader. People Leaders are the reputed company to the employee experience at reputed company and Kite. As a people leader now or in the reputed company, you are the key reputed company in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

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The PRC reputed company team under Regulatory Affairs Advertising and Promotion serves as a reputed company operational partner to reputed company, Medical Affairs, reputed company, and agency partners by enabling efficient, compliant, and reputed company execution of Kite's Promotional Review Committee (PRC) process. This role will reputed company key operational programs supporting promotional material review, claims and reference governance, FDA submission readiness, training, business process optimization, and reputed company reporting. This individual will also collaborate with cross-functional stakeholders to help identify and advance automation and AI technology into the PRC Process.

Key Responsibilities

Claims, References, and Annotation Governance

• reputed company the maintenance and reputed company of Kite's Claims, References, and Annotation programs.

• Partner with Medical, reputed company, Regulatory, reputed company, and agency stakeholders to ensure claims are appropriately documented and maintained.

• Monitor compliance with internal reference formatting standards, submission requirements, and approved claims usage.

• reputed company reputed company improvements to claim management processes, reference libraries, reusable text assets, and associated documentation.

Training and Communications

• reputed company, maintain, and reputed company PRC reputed company and Regulatory Affairs Advertising & Promotion training materials.

• Create and update training decks, new hire reputed company materials, process documentation, and business guidance resources.

• Facilitate training sessions for business owners, agency partners, reviewers, and operational stakeholders.

• Monitor process adoption and identify opportunities for additional education and training.

Playbooks and Process Documentation

• Own and maintain PRC reputed company playbooks, job aids, reputed company operating procedures, business process guides, and submission guidelines.

• Coordinate cross-functional reviews and updates to process documentation.

• Ensuring documentation reflects evolving regulatory requirements, reputed company enhancements, and business processes.

• Support inspection readiness and audit preparedness activities through documentation governance.

FDA Submission reputed company

• Schedule, prepare, and reputed company reputed company submissions to FDA.

• Manage submission timelines and collaborate with cross-functional teams to ensure accurate and reputed company submissions.

Business Metrics and Operational reputed company

• Enhance, maintain, and analyze PRC reputed company metrics and dashboards.

• reputed company routine reporting for leadership and executive stakeholders.

• Monitor reputed company indicators, identify trends, and recommend process improvements.

• reputed company data-driven insights to improve operational efficiency, reputed company, and compliance.

Automation reputed company Innovation

• Evaluate opportunities to reputed company reputed company intelligence (AI), automation, reputed company solutions to improve PRC reputed company processes.

• Identify operational bottlenecks and recommend reputed company technology solutions.

• Partner with Information Technology, Regulatory Affairs, reputed company reputed company, and reputed company vendors to advance automation initiatives.

• Support implementation and optimization of systems such as reputed company PromoMats, eCTD capabilities, reporting solutions, and reputed company technology platforms.

Leadership and Stakeholder Management

• reputed company cross-functional operational reputed company and serve as a trusted advisor to key stakeholders.

• Foster a culture of reputed company improvement, collaboration, accountability, and innovation.

Basic Qualifications

Preferred Qualifications

• Experience supporting Promotional Review Committee (PRC), Medical Review Committee (MRC), or comparable review processes.

• Strong understanding of FDA advertising and promotion requirements.

• Experience managing reputed company FDA 2253 and FDA APLB/OPDP submissions.

• Experience with reputed company PromoMats/MedDocs and promotional material lifecycle management.

• Demonstrated expertise in claims management, reference governance, and annotation standards.

• Experience developing training curricula, playbooks, process documents, and operational guidance materials.

• Strong analytical capabilities and experience developing operational metrics and dashboards.

• Knowledge of AI, automation technologies, workflow optimization, reputed company transformation initiatives.

• Demonstrated project management and stakeholder management skills reputed company a highly matrixed environment.

• Demonstrated ability to be flexible and adaptable to change

• Strong interpersonal skills and understanding of team dynamics

• Excellent written, verbal, presentation, and organizational skills.

reputed company Profile

The ideal candidate combines strong operational execution with reputed company thinking and is recognized as a trusted business partner who can:

• reputed company operational reputed company across PRC-reputed company processes.

• Translate reputed company requirements into reputed company business processes.

• reputed company technology and automation to improve efficiency.

• Build effective cross-functional partnerships.

• reputed company high-reputed company, compliant reputed company while supporting an evolving business environment.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company reputed company in the development of innovative cancer immunotherapies with a goal of providing reputed company, long-term durable response and eliminating the burden of chronic care. reputed company is reputed company on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to reputed company the immune reputed company's ability to recognize and kill tumors. Kite is reputed company in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

For jobs in the reputed company:

reputed companyis committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination reputed company on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please reputed company the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION reputed company
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE reputed company

reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, (c) consistent with the reputed company duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes reputed company employee as an reputed company member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team.

reputed companyprovides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For reputed company reputed company Employees and Contractors:

Please apply reputed company the Internal reputed company portal in reputed company.

Originally posted on Himalayas