Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee operational programs that support the review of promotional materials, governance of claims and references, readiness for FDA submissions, training, optimization of business processes, and performance reporting.

• Develop and enhance Kite's Claims, References, and Annotation initiatives.

• Collaborate with Medical, Legal, Regulatory, Commercial, and agency stakeholders on the documentation and maintenance of claims.

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

• Streamline claim management processes, reference libraries, reusable text assets, and documentation practices.

• Create, update, and deliver training materials for PRC Operations and Regulatory Affairs in Advertising & Promotion.

• Develop training presentations, onboarding resources, process documentation, and guidance materials for business operations.

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

• Manage and update PRC Operations playbooks, job aids, standard operating procedures, process guides, and submission guidelines.

• Coordinate cross-functional reviews and revisions of process documentation.

• Assist in maintaining readiness for inspections and audits through governance of documentation.

• Organize, prepare, and perform quality checks on FDA submissions.

• Oversee submission timelines in collaboration with cross-functional teams.

• Improve, maintain, and analyze metrics and dashboards for PRC Operations.

• Produce regular reports for leadership and executive stakeholders.

• Identify trends and propose process enhancements based on data-driven insights.

• Assess and promote AI, automation, and digital solutions for PRC Operations.

• Work with Information Technology, Regulatory Affairs, Commercial Operations, and external vendors on automation projects.

• Aid in the implementation and optimization of Veeva PromoMats, eCTD capabilities, reporting solutions, and future technology platforms.

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

• Promote continuous improvement, teamwork, accountability, and innovation.

⛳️ Requirements

• Bachelor's Degree with 6+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business Operations, or related pharmaceutical/biotechnology fields; or a Master's Degree with 4+ years of experience in those areas.

• Proven experience supporting a Promotional Review Committee (PRC), Medical Review Committee (MRC), or similar review processes.

• Strong knowledge of FDA advertising and promotion regulations.

• Experience managing Form FDA 2253 and submissions to FDA APLB/OPDP.

• Familiarity with Veeva PromoMats/MedDocs and the lifecycle management of promotional materials.

• Proficient in claims management, governance of references, and standards for annotation.

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

• Solid analytical skills and experience in developing operational metrics and dashboards.

• Knowledge of AI, automation technologies, workflow optimization, and digital transformation efforts.

• Project management and stakeholder engagement skills in a highly matrixed environment.

• Ability to be adaptable and flexible in response to change.

• Strong interpersonal skills and a solid understanding of team dynamics.

• Exceptional written, verbal, presentation, and organizational abilities.

🏝️ Benefits

• Eligibility for a discretionary annual bonus.

• Potential eligibility for discretionary stock-based long-term incentives, which may vary by role.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.