Manager, Regulatory Affairs (AI)

Location: United States – Remote

Salary: $133,195–$172,370 per year, plus potential discretionary annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

• Lead claims, references, and annotation governance for promotional materials.
• Coordinate promotional review operations with Legal, Medical Affairs, Commercial, Regulatory, and agency stakeholders.
• Develop and deliver training, onboarding materials, playbooks, standard operating procedures, and process guidance.
• Schedule, prepare, and quality-check FDA submissions while managing submission timelines.
• Maintain operational metrics and dashboards, analyze performance trends, and recommend process improvements.
• Evaluate and implement AI, automation, Veeva PromoMats, eCTD, reporting, and other digital solutions.

Requirements

• Bachelor's degree and 6+ years of relevant experience, or master's degree and 4+ years of relevant experience in regulatory, promotional review, commercial, medical affairs, or related pharmaceutical/biotechnology operations.
• Experience with promotional review committees or comparable review processes.
• Strong understanding of FDA advertising and promotion requirements, including Form FDA 2253 and FDA APLB/OPDP submissions.
• Experience with Veeva PromoMats/MedDocs, promotional material lifecycle management, claims management, reference governance, and annotation standards.
• Strong analytical, project management, stakeholder management, communication, presentation, and organizational skills.
• Employment is for a remote role in the United States.

Nice to have

• Experience developing training curricula, playbooks, process documents, and operational guidance.
• Knowledge of AI, automation, workflow optimization, and digital transformation.
• Experience developing operational metrics and dashboards in a highly matrixed environment.

Culture & Benefits

• Mission focused on developing innovative cancer therapies and creating durable responses.
• Emphasis on inclusion, employee development, empowerment, collaboration, accountability, and continuous improvement.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off and potential annual bonus and stock-based long-term incentives may be available.