Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)

Location: Brisbane, California, United States; onsite role

Salary: $232,000–$274,000 for Director; $279,000–$331,000 for Senior Director

Company

hirify.global is a biotechnology company developing oncology therapeutics and advancing investigational and marketing applications.

What you will do

• Develop and execute global regulatory strategies for oncology solid tumor programs, supporting product development, registration, regional labeling, and life cycle management.
• Lead the preparation of global submissions, including INDs, CTAs, NDAs, and MAAs, for early- and late-stage programs.
• Plan and support interactions with global Health Authorities, including the FDA and EMA, and interpret regulatory feedback.
• Represent Regulatory Affairs on cross-functional development teams and guide risk mitigation for regulatory and development challenges.
• Develop submission plans, track deliverables and dependencies, and maintain standardized planning templates across programs.
• Help define and implement document management, submission content planning, and regulatory information management 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 oncology solid tumor experience.
• Strong knowledge of drug development and FDA, EMA, and ICH guidelines and regulations.
• Hands-on experience planning and executing clinical trial and marketing applications and major regulatory filings.
• Strong project management, critical thinking, organizational, written, and verbal communication skills.
• Experience with regulatory submission planning tools such as Veeva RIM, Smartsheet, and Excel trackers.

Culture & Benefits

• Highly collaborative, team-oriented working environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful culture open to diverse points of view.
• Opportunity to manage consultants and contractors as needed.