Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Location: United States - Remote

Annual salary: USD 215,204.70–291,159.30

Company

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

What you will do

• Lead Global Regulatory Teams within the Global Regulatory Affairs organization.
• Develop and execute global regulatory strategies for complex, late-stage oncology programs and products with multiple indications.
• Represent Regulatory Affairs on product teams and commercialization governance bodies, influencing regulatory objectives and decisions.
• Plan and lead global regulatory filings, including clinical trial applications, marketing applications, and label extensions.
• Guide regulatory agency interactions, product communication, core data sheet development, and global labeling strategies.
• Assess regulatory changes, identify risks, and evaluate mechanisms such as Fast Track, Orphan Drug Designation, accelerated approval, compassionate use, and pediatric plans.

Requirements

• Doctorate degree and 5 years of regulatory experience in biotechnology or science; or master’s degree and 9 years; or bachelor’s degree and 11 years.
• At least 5 years of direct people management or experience leading teams, projects, programs, or resource allocation.
• Experience leading regulatory aspects of highly complex programs in late development.
• Strong oral and written communication skills and the ability to understand and communicate scientific and clinical information.
• Ability to anticipate and mitigate strategic risks, resolve conflicts, make complex decisions, and manage ambiguity.
• Planning, prioritization, negotiation, cultural awareness, and organizational skills.

Nice to have

• Contemporary oncology experience.
• Experience leading regulatory submissions and approvals for original marketing applications or major supplemental applications.
• Experience building effective regulatory teams.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable.