Senior Director, Global Regulatory Strategy, Oncology

Location: Cambridge, Massachusetts, United States; hybrid 70/30 work model with 70% in-office collaboration. Only U.S. persons are 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 mRNA technology and medicines through a biotechnology and scientific research platform.

What you will do

• Lead global regulatory strategies for oncology programs from early development through commercialization.
• Drive IND, CTA, BLA, MAA, and other regulatory submissions.
• Lead interactions and high-stakes negotiations with FDA, EMA, PMDA, and other health authorities.
• Shape regulatory pathways for novel and first-in-class oncology therapies.
• Partner with cross-functional teams and alliances to align regulatory strategies.
• Anticipate and mitigate regulatory risks while building high-performing regulatory teams.

Requirements

• BA/BS degree in a scientific or engineering discipline.
• 12+ years of experience in the pharmaceutical industry and 8+ years in regulatory strategy, including oncology.
• Strong knowledge of current U.S. and EU regulations, novel regulatory pathways, CTD format, and regulatory filing content.
• Track record of developing competitive regulatory strategies, securing product approvals, and managing complex portfolios.
• Experience leading regulatory authority meetings across different phases of drug development.
• Demonstrated employee management, stakeholder engagement, and exceptional written and oral communication skills.

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.
• Experience making high-quality decisions under ambiguity and pressure and driving innovation.

Culture & Benefits

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