US Regulatory Lead (Biotech)

Location: United States - Remote

Salary: USD 112,744–152,536 annually

Company

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

What you will do

• Plan and execute US regulatory strategies for assigned products across development, registration, and lifecycle management.
• Prepare and manage marketing authorization and lifecycle submissions in line with FDA requirements and corporate standards.
• Develop, review, and maintain US product labeling, artwork, promotional materials, and non-promotional materials.
• Act as a point of contact for FDA interactions, including preparation for agency meetings and fulfillment of local obligations.
• Advise global, regional, and cross-functional teams on US regulatory requirements affecting clinical development and marketing applications.
• Monitor legislation, regulatory guidance, product compliance commitments, safety communications, and opportunities such as expedited designations and orphan drug programs.

Requirements

• Doctorate degree; or a master’s degree with 3 years of US regulatory experience; or a bachelor’s degree with 5 years; or an associate’s degree with 10 years; or a high school diploma/GED with 12 years.
• Experience directly managing people or leading teams, projects, programs, or resource allocation.
• Experience with US regulatory submissions and interactions with the FDA.
• Knowledge of US legislation and regulations for medicinal products, regulatory principles, and drug development.
• Ability to communicate scientific and clinical information, negotiate, influence, resolve conflicts, and collaborate across international teams.
• Must be located in the United States for this remote role.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans, work-life balance support, and career development opportunities.
• Sponsorship is not guaranteed.