Manager, Regulatory Affairs

About this role

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 ope

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