Sr. Director, Global Regulatory Strategy, Oncology (mRNA)

Location: Cambridge, Massachusetts, United States; 70% in-office work model

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

Company

hirify.global develops mRNA therapeutics and vaccines using its messenger RNA technology platform, delivery technology, and manufacturing capabilities.

What you will do

• Lead global regulatory strategy and development plans for assigned oncology programs involving mRNA therapeutics.
• Set the strategic direction and oversee the content, format, and accountability of regulatory submissions, supplements, and amendments.
• Advise project teams throughout clinical and nonclinical development and identify regulatory risks, opportunities, and process improvements.
• Build relationships with global health agencies, lead regulatory meetings, respond to data requests, and negotiate filings.
• Review technical and clinical data, external materials, target label profiles, and company core data sheets for regulatory compliance.
• Manage regulatory resources, budgets, deliverables, and potentially direct reports.

Requirements

• BA/BS degree in a scientific or engineering discipline.
• 12+ years of experience in the pharmaceutical industry, including 8+ years in regulatory strategy with oncology experience.
• Strong knowledge of current US and EU regulations, including novel regulatory pathways.
• Extensive experience with CTD format and regulatory filing content.
• Demonstrated success securing product approvals and managing complex portfolios.
• Experience leading regulatory authority meetings and managing internal and external stakeholders.

Nice to have

• Graduate degree in a scientific or relevant discipline or professional certification.
• Experience delivering at least one major NDA, BLA, MAA, JNDA, or comparable application.

Culture & Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific benefits.
• In-person collaboration supported through a 70/30 office-based working model.