Global Regulatory Affairs Director - Inflammation and Rare Disease (Biotech)

Location: United States — Remote

Salary: $189,632.45–$256,561.55 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

• Develop and execute global regulatory product strategies for inflammation and rare disease therapies.
• Lead Global Regulatory Teams and represent Regulatory Affairs on product and commercialization governance teams.
• Create regulatory strategic plans and registration strategies supporting development, approval, labeling, and lifecycle maintenance.
• Lead global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes.
• Assess regulatory risks, guidance, precedents, and mechanisms such as Fast Track, Orphan Drug, accelerated approval, compassionate use, and pediatric plans.
• Lead regulatory agency communications and participate in key agency meetings and external product partnerships.

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.
• Ability to lead and build effective teams.
• Strong oral and written communication skills, including the ability to explain scientific and clinical information.
• Ability to anticipate strategic issues, resolve conflicts, make complex decisions, and manage ambiguity.
• Ability to prioritize and manage multiple activities in a global environment.

Culture & Benefits

• Health, dental, vision, life, and disability insurance, plus flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and work-life balance support.
• Career development opportunities and flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.