Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Location: Onsite in Brisbane, California, United States

Salary: $220,000–$254,000 annually, plus bonus and equity.

Company

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

What you will do

• Develop and implement global clinical and nonclinical regulatory strategies for immunology and inflammation indications.
• Serve as the global regulatory lead and represent Regulatory Affairs on cross-functional development teams.
• Lead the preparation and execution of global IND, CTA, NDA, and MAA submissions.
• Plan and lead interactions with global health authorities, including the FDA and EMA, and interpret agency feedback.
• Identify regulatory risks, guide mitigation strategies, and ensure compliance with regulations and company SOPs.
• Coordinate submission plans, deliverables, dependencies, regulatory information, and related systems and tools.

Requirements

• Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree is preferred.
• Minimum 12 years of experience in Regulatory Affairs strategy, including significant immunology and inflammation experience.
• Strong knowledge of drug development and FDA, EMA, and ICH guidelines and regulations.
• Experience planning clinical trials and marketing applications and supporting major filings and application maintenance.
• Experience using project management techniques and tools such as MS Project, Smartsheet, and Excel trackers.
• Strong project management, critical thinking, organizational, written, verbal, and interpersonal communication skills.

Culture & Benefits

• Cross-functional work with Regulatory Affairs, clinical development, development teams, CROs, consultants, and contractors.
• Opportunity to contribute to regulatory submission processes, document management, submission content planning, and regulatory information systems.
• Compensation includes annual salary, bonus, and equity.