Senior Director, Regulatory Affairs (Oncology)

Location: Alameda, California, United States; office-based working environment with approximately 20% travel.

Salary: $248,000–$352,500 annually, depending on geographic market, qualifications, experience, and internal equity.

Company

hirify.global develops oncology medicines and manages global clinical and regulatory programs.

What you will do

• Drive global regulatory strategies aligned with asset goals, corporate objectives, and health authority requirements.
• Interact with regulatory authorities and provide regulatory intelligence, risk assessments, and recommendations on potential expedited pathways.
• Represent Regulatory Affairs on multidisciplinary teams supporting early- and late-stage development programs.
• Plan, review, prepare, submit, and maintain CTAs across Europe, Asia, and other regions in collaboration with external vendors.
• Review clinical trial documentation and lead the preparation and evaluation of high-quality regulatory submissions.
• Oversee multiple assets or studies, contribute to SOPs and work instructions, and directly supervise employees.

Requirements

• Bachelor’s degree and at least 15 years of related experience, master’s degree and at least 13 years, PhD and at least 12 years, or an equivalent combination.
• Extensive knowledge of regulatory requirements, industry practices, and regulatory strategy for clinical development programs.
• Experience developing plans, timelines, performance standards, priorities, and contingency strategies for multiple activities.
• Strong stakeholder management, communication, conflict-resolution, and cross-functional collaboration skills.
• Ability to analyze complex information, solve regulatory problems, influence decisions, and lead teams with accountability and integrity.

Culture & Benefits

• Collaborative office environment designed to support close teamwork and knowledge sharing.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• 401(k) plan with company contributions, stock purchase opportunities, and long-term incentives.
• Discretionary annual bonus program.
• 15 accrued vacation days in the first year, 17 paid holidays including a winter shutdown, and up to 10 sick days annually.
• Office equipment includes dual monitors and ergonomic chairs.