Sr. Director, Global Regulatory Strategy, Oncology

Location: Cambridge, Massachusetts, with a 70/30 in-office work model. Only U.S. persons are eligible due to U.S. export control requirements.

Salary: $196,700–$353,400 annually, with potential bonus, incentive compensation, or equity awards.

Company

hirify.global develops medicines using its mRNA technology platform.

What you will do

• Develop and execute global regulatory strategies and development plans for assigned oncology programs.
• Lead the content, format, accountability, and management of regulatory submissions, supplements, and amendments.
• Advise clinical and nonclinical development teams, identify regulatory risks, and respond to changing regulations.
• Lead interactions and negotiations with global health agencies, including preparation for regulatory meetings and responses to data requests.
• Review clinical and technical data, external materials, labeling profiles, and core data sheets for regulatory accuracy and compliance.
• Manage regulatory resources and budgets, develop employees, and lead process improvements.

Requirements

• BA/BS degree in a scientific or engineering discipline.
• 12+ years of pharmaceutical industry experience and 8+ years in regulatory strategy, including oncology.
• Strong knowledge of U.S. and EU regulations, novel regulatory pathways, CTD format, and regulatory filings.
• Experience developing competitive regulatory strategies, securing product approvals, and managing complex portfolios.
• Experience leading regulatory authority meetings across different phases of drug development and working with internal and external stakeholders.
• Must qualify as a U.S. person; non-U.S. persons are not eligible, and visa sponsorship is unavailable.

Nice to have

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

Culture & Benefits

• 70/30 in-office work model focused on collaboration, innovation, and mentorship.
• 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.