Global Regulatory Affairs Director (Inflammation and Rare Disease)

Location: United States - Remote

Salary: USD 189,632.45–256,561.55 annually

Company

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

What you will do

• Develop and execute global regulatory product strategies for inflammation and rare disease products.
• Lead Global Regulatory Teams and represent Regulatory Affairs on product and commercialization governance teams.
• Create regulatory strategic plans, registration strategies, and plans for global product labeling and lifecycle maintenance.
• Lead global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes.
• Assess global regulations, regulatory pathways, risks, and opportunities such as Orphan Drug, Fast Track, accelerated approval, compassionate use, and pediatric plans.
• Lead regulatory agency interactions, key agency meetings, cross-functional teams, and external partnership engagements.

Requirements

• Doctorate degree and 4 years of regulatory experience in biotech or science; or master’s degree and 7 years of experience; or bachelor’s degree and 9 years of experience.
• Experience developing and communicating scientific and clinical information.
• Ability to lead and build effective teams, manage multiple activities, and prioritize complex work.
• Strong written and oral communication, negotiation, decision-making, and problem-solving skills.
• Ability to anticipate and mitigate strategic risks, resolve conflicts, and work effectively with ambiguity.
• Cultural awareness and sensitivity to achieve global results.

Culture & Benefits

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