Sr. Director, Regulatory Strategy, Infectious Disease

Location: Cambridge, Massachusetts headquarters or one of hirify.global’s East Coast hubs; 70% in-office work model. Only U.S. persons eligible due to U.S. export control requirements.

Salary: $196,700–$353,400 per year, with potential bonus, incentive compensation, or equity eligibility.

Company

hirify.global develops medicines and vaccines using its mRNA technology platform.

What you will do

• Lead global regulatory strategy for assigned infectious disease and vaccine development programs.
• Set the direction and oversee the content, format, and accountability of regulatory submissions, supplements, and amendments.
• Advise cross-functional project teams throughout clinical and nonclinical development, identifying regulatory risks, gaps, and opportunities.
• Build relationships with global health agencies, lead regulatory meetings, respond to data requests, and negotiate on company filings.
• Review technical and clinical data, support trial and filing activities, and ensure regulatory systems remain accurate and compliant.
• Manage regulatory resources, budgets, process improvements, and a team of regulatory strategists supporting COVID-facing programs.

Requirements

• BA/BS degree in a scientific or engineering discipline; an advanced degree is preferred.
• 12+ years of pharmaceutical industry experience and 8+ years in regulatory strategy, including vaccine development.
• Expertise in FDA, EU, and ICH guidelines and regulations for infectious disease vaccine programs.
• Strong experience with CTD format and content, regulatory filings, product approvals, and complex portfolios.
• Experience developing competitive regulatory strategies and leading health authority meetings across drug development phases.
• Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons are not eligible and sponsorship is unavailable.

Nice to have

• Experience in infectious diseases and vaccine development across multiple therapeutic areas.
• Delivery of at least one major NDA, BLA, MAA, JNDA, or similar application.
• Advanced degree and experience managing or developing direct reports.

Culture & Benefits

• 70/30 in-office working model emphasizing collaboration, innovation, teamwork, and mentorship.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.