Manager, Regulatory Affairs

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

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

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 Kite and help create more tomorrows.

Job Description

The PRC Operations team under Regulatory Affairs Advertising and Promotion serves as a strategic operational partner to Legal, Medical Affairs, Commercial, and agency partners by enabling efficient, compliant, and scalable execution of Kite's Promotional Review Committee (PRC) process. This role will lead key operational programs supporting promotional material review, claims and reference governance, FDA submission readiness, training, business process optimization, and performance 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

• Lead the maintenance and evolution of Kite's Claims, References, and Annotation programs.

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

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

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

Training and Communications

• Develop, maintain, and deliver PRC Operations and Regulatory Affairs Advertising & Promotion training materials.

• Create and update training decks, new hire onboarding 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 Operations playbooks, job aids, standard operating procedures, business process guides, and submission guidelines.

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

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

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

FDA Submission Operations

• Schedule, prepare, and quality check submissions to FDA.

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

Business Metrics and Operational Excellence

• Enhance, maintain, and analyze PRC Operations metrics and dashboards.

• Generate routine reporting for leadership and executive stakeholders.

• Monitor performance indicators, identify trends, and recommend process improvements.

• Leverage data-driven insights to improve operational efficiency, quality, and compliance.

Automation and Digital Innovation

• Evaluate opportunities to leverage artificial intelligence (AI), automation, and digital solutions to improve PRC Operations processes.

• Identify operational bottlenecks and recommend scalable technology solutions.

• Partner with Information Technology, Regulatory Affairs, Commercial Operations, and external vendors to advance automation initiatives.

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

Leadership and Stakeholder Management

• Lead cross-functional operational projects and serve as a trusted advisor to key stakeholders.

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

Basic Qualifications

• Bachelor's Degree AND 6+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business Operations, or related pharmaceutical/biotechnology functions OR

• Master's Degree AND 4+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business Operations, or related pharmaceutical/biotechnology functions

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 Form FDA 2253 and FDA APLB/OPDP submissions.

• Experience with Veeva 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, and digital transformation initiatives.

• Demonstrated project management and stakeholder management skills within 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.

Success Profile

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

• Drive operational excellence across PRC-related processes.

• Translate complex requirements into scalable business processes.

• Leverage technology and automation to improve efficiency.

• Build effective cross-functional partnerships.

• Deliver high-quality, compliant outcomes while supporting an evolving business environment.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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

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

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

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

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access 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 access 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 action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.