Senior Director, Regulatory Affairs (Oncology)

Location: Hybrid, based on the primary position location in Emeryville, California, United States. Travel required: 20%.

Salary: $250,000–$285,000 per year.

Company

hirify.global develops cancer treatments using the PROBODY therapeutic platform, with a clinical-stage pipeline spanning antibody-drug conjugates, T-cell engagers, and immune modulators.

What you will do

• Lead integrated global regulatory strategies for late-stage programs, particularly in the United States and European Union.
• Drive major regulatory filings, including planning, content development, cross-functional coordination, and responses to health-authority questions.
• Lead FDA meeting strategy and preparation, including briefing materials, rehearsals, participation, and follow-up.
• Guide regulatory pathways, registration planning, submission activities, and health-authority interactions.
• Advise senior leadership and cross-functional teams on regulatory risks, opportunities, clinical development, pivotal study design, labeling, and evidence generation.
• Build relationships with regulators, partners, consultants, and internal stakeholders while mentoring colleagues and improving regulatory practices.

Requirements

• Bachelor’s degree in a scientific discipline such as biology, medicine, or pharmacy; an advanced PharmD, PhD, or MD is preferred.
• At least 10 years of progressive regulatory affairs experience in biotechnology or pharmaceuticals, including global late-stage development and registration strategy.
• Experience leading health-authority interactions, registration planning or execution, and major regulatory filings or marketing applications.
• Substantial experience preparing for and participating in regulatory agency meetings.
• Strong knowledge of global drug-development requirements and the ability to lead complex cross-functional work and advise senior stakeholders.
• Hybrid work arrangement based in Emeryville, California, with 20% travel required.

Nice to have

• Oncology and/or biologics regulatory experience.
• Regulatory development, health-authority interaction, or filing experience in China and/or Japan.
• Experience with expedited pathways, external partnerships, and small to mid-sized biotechnology environments.

Culture & Benefits

• Collaborative workplace focused on open communication, teamwork, patient impact, and innovation.
• Learning curriculum and career guidance supporting professional development.
• Competitive total rewards program designed to support compensation goals and work-life balance.
• Background investigation required, consistent with applicable law.