Associate Director, Global Regulatory Affairs Compliance

Location: Hybrid role based in the Cambridge, Massachusetts, or San Francisco, California office, with onsite attendance at least two days per week; approximately 10% travel required.

Salary: $190,000–$210,000 annually, plus equity, bonus, and benefits.

Company

hirify.global is a clinical-stage biopharmaceutical company developing therapies for breast cancer and other oncology indications, including palazestrant and OP-3136.

What you will do

• Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies for development programs.
• Support the timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to INDs, NDAs, health authority meeting materials, correspondence, and other regulatory submissions.
• Review submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.

Requirements

• Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred.
• At least 8 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Experience interpreting and applying applicable laws, regulations, and regulatory guidance.
• Technical and regulatory writing experience.
• Strong organizational, project management, problem-solving, communication, and presentation skills.
• Ability to work independently, collaborate across functions, manage multiple priorities, and adapt to changing deadlines.

Culture & Benefits

• Open, flexible, and collaborative work environment.
• Competitive compensation and benefits package.
• Equity and bonus included in the total compensation package.
• Equal-opportunity workplace focused on inclusion, learning, growth, and professional development.