Executive Director, Regulatory Strategy (Oncology)

Location: Alameda HQ, Alameda, California, United States

Salary: $268,500–$380,000 annually

Company

hirify.global is a pharmaceutical company developing oncology medicines and managing global regulatory programs.

What you will do

• Lead regulatory activities for development programs from pre-IND through BLA/NDA submission and post-approval.
• Develop and implement global regulatory strategies across clinical, non-clinical, and CMC disciplines.
• Oversee Regulatory Program Leaders, clinical regulatory teams, staff development, and departmental initiatives.
• Direct preparation and review of INDs, NDAs, BLAs, safety reports, correspondence, and supporting clinical documentation.
• Manage meetings and interactions with the FDA and other health authorities to support efficient review and approval.
• Collaborate with internal functions, vendors, licensors, and joint development partners.

Requirements

• BS/BA with at least 18 years of related experience, MS/MA with at least 16 years, or PhD with at least 15 years, or an equivalent combination.
• At least 18 years of pharmaceutical industry and/or regulatory agency experience.
• At least nine years of regulatory experience in a position of substantial responsibility.
• Prior experience working with relevant FDA review divisions.
• Experience in oncology drug development is required.
• Knowledge of US and international regulatory requirements, strong analytical and business communication skills, and experience managing teams.

Culture & Benefits

• Indoor office-based work in a collaborative environment.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• 401(k) plan with company contributions and eligibility for an annual discretionary bonus.
• Company stock purchase opportunities and long-term incentives.
• 15 vacation days in the first year, 17 paid holidays including a winter shutdown, and up to 10 sick days annually.