Associate Regulatory Affairs Strategy Director (Oncology)

Location: Alameda, California, United States; office-based environment.

Salary: $195,000–$277,500 annually, adjusted according to the candidate’s U.S. geographic market and experience.

Company

hirify.global develops oncology medicines and operates cross-functional regulatory and clinical development programs.

What you will do

• Develop and implement 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 oncology programs.
• Plan, review, prepare, submit, and maintain CTAs across Europe, Asia, and other regions with external vendors.
• Coordinate and oversee IND, NDA, BLA, DSUR, safety report, amendment, supplement, and other regulatory submissions.
• Lead multiple assets or studies and collaborate with internal departments, vendors, licensors, consultants, and joint development partners.

Requirements

• Bachelor’s degree with at least 11 years of related experience, or a master’s degree with at least 9 years, or a PhD with at least 5 years, or an equivalent combination.
• Broad knowledge of regulatory frameworks and industry practices, with the ability to manage complex regulatory work.
• Experience reviewing clinical trial documentation, including protocols, informed consents, and clinical study reports.
• Ability to manage multiple activities, prioritize work, resolve regulatory challenges, and deliver within established timelines.
• Strong written, verbal, interpersonal, collaboration, and stakeholder-management skills.
• Approximately 10% travel is required.

Culture & Benefits

• Collaborative office environment designed to support close teamwork, idea sharing, and problem-solving.
• Company-provided equipment, including dual monitors and ergonomic chairs.
• 401(k) plan with company contributions, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Annual discretionary bonus eligibility, stock purchase opportunities, and long-term incentives.
• Fifteen accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.