Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Location: Brisbane, California, United States — onsite

Salary: $187,800–$208,638 for Senior Manager; $199,500–$231,200 for Associate Director

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases using an AI-integrated discovery engine and ligase expertise.

What you will do

• Provide regulatory strategic direction and support for global hematology-oncology development programs.
• Design and implement strategies for investigational and marketing applications, including lifecycle management.
• Represent Regulatory Affairs on early- and late-phase clinical studies and support compliant trial execution.
• Prepare and maintain Annual Reports, DSURs, Investigator’s Brochures, INDs, CTAs, NDAs, and related submissions.
• Develop submission plans, track deliverables and dependencies, and support regulatory information management systems.
• Collaborate with cross-functional teams, manage consultants and contractors, and develop mitigation strategies for regulatory risks.

Requirements

• Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree is preferred.
• Minimum of 8 years of experience in regulatory affairs strategy.
• Knowledge of drug development and FDA, EMA, and ICH guidelines and regulations.
• Hands-on experience planning clinical trial and marketing applications for health authorities.
• Experience supporting major filings, maintaining clinical trial and marketing applications, and managing regulatory submissions.
• Strong project management, critical thinking, organization, communication, and collaboration skills.

Culture & Benefits

• Highly collaborative, team-oriented working environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful work style with openness to diverse perspectives.
• Onsite work in Brisbane, California.