Senior Director, Regulatory Affairs - Global Regulatory Leader Oncology (Oncology)

Location: Washington D.C., District of Columbia, United States

Company

hirify.global is a biotechnology company developing and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead Global Regulatory Teams supporting complex oncology programs in late-stage development.
• Develop and execute global regulatory strategies for product development, registration, labeling, and lifecycle management.
• Lead planning and implementation of clinical trial applications, marketing applications, label extensions, and other global regulatory filings.
• Represent Regulatory Affairs on product teams, commercialization governance bodies, partnership teams, and interactions with regulatory agencies.
• Assess regulatory mechanisms such as Fast Track, Orphan Drug Designation, accelerated approval, compassionate use, and pediatric plans.
• Drive regulatory process improvements and communicate regulatory risks, mitigations, and contingencies.

Requirements

• Doctorate degree and 5 years of regulatory experience in biotech or science; or a master’s degree and 9 years of experience; or a bachelor’s degree and 11 years of experience.
• At least 5 years of direct people management or leadership experience across teams, projects, programs, or resource allocation.
• Experience leading regulatory aspects of highly complex late-development programs.
• Strong written and verbal communication, scientific and clinical understanding, decision-making, conflict resolution, and organizational skills.
• Ability to anticipate strategic issues, manage ambiguity, prioritize multiple activities, and lead effective teams.

Nice to have

• Contemporary oncology experience.
• Experience leading submissions and approvals for original marketing applications or major supplemental indications.
• Cultural awareness, negotiation skills, and experience achieving global regulatory outcomes.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plans with company contributions.
• Annual bonus opportunities, stock-based long-term incentives, and paid time off.
• Flexible work models where applicable, depending on the work location type.

Hiring process

• Applications are accepted until a candidate is selected; no fixed deadline is specified.
• Visa sponsorship is not guaranteed.