Director, Regulatory Affairs (Biotech)

Location: Jersey City, NJ, United States; minimum 3 days per week onsite

Salary: $213,000–$257,250 per year, plus bonus and equity compensation

Company

hirify.global Therapeutics is a biopharmaceutical company developing novel treatments through technology combining chemistry, engineering, computation, and biology.

What you will do

• Provide strategic and hands-on regulatory support across clinical development programs.
• Develop and execute regulatory strategies supporting product development, approval, and commercialization.
• Lead or support preparation, review, and submission of INDs, NDAs, and MAAs.
• Monitor evolving regulations, guidance, and industry practices to maintain program compliance.
• Partner with Clinical Development, R&D, Quality, and other cross-functional stakeholders.
• Identify regulatory risks and recommend mitigation strategies, including for GCP and GLP requirements.

Requirements

• Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a bachelor’s degree with 12+ years of experience.
• Strong knowledge of FDA and international regulatory requirements, including EU, Japan, and China.
• Experience developing clinical regulatory content and strategy and managing regulatory submissions.
• Excellent written and verbal communication, analytical, organizational, and problem-solving skills.
• Ability to operate as a senior individual contributor and influence cross-functional stakeholders.
• Ability to work onsite in the Jersey City office at least 3 days per week.

Nice to have

• Experience supporting oncology development programs.

Culture & Benefits

• Collaborative, fast-paced, high-growth working environment.
• 401(k) plan with company matching.
• Medical, dental, vision, mental health, wellness, life, and AD&D benefits.
• Generous paid time off, holiday policies, and weeklong summer and winter shutdowns.
• Enhanced parental leave and a subsidized daily lunch program when onsite.