Sr. Director, Regulatory Affairs (Biotech)

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

Salary: $235,000–$288,750 per year, plus bonus and equity compensation

Company

hirify.global Therapeutics is a biopharmaceutical company developing treatments for life-threatening diseases through a discovery platform combining chemistry, engineering, computation, biology, and real-time molecular-resolution microscopy.

What you will do

• Develop and execute regulatory strategies supporting product development, approval, and commercialization.
• Monitor evolving regulations, guidelines, and industry practices to maintain regulatory compliance.
• Oversee preparation, review, and submission of IND, NDA, and MAA documentation.
• Provide regulatory guidance to R&D, Quality Assurance, Clinical Development, and other cross-functional teams.
• Supervise regulatory aspects of quality systems, including compliance with GCP and Good Laboratory Practices.
• Identify regulatory risks and develop mitigation strategies.

Requirements

• Postgraduate degree with 12+ years of experience, or bachelor's degree with 15+ years of relevant experience.
• In-depth knowledge of FDA and international regulatory requirements and guidelines.
• Strong communication, negotiation, project management, analytical, and problem-solving skills.
• Experience collaborating effectively with cross-functional teams.
• Adaptability and the ability to work in a fast-paced, high-growth environment.
• Ability to work onsite in the Jersey City office at least 3 days per week.

Culture & Benefits

• 401(k) plan with company matching.
• Medical, dental, and vision insurance with substantial premium coverage.
• Mental health and wellness benefits.
• Weeklong summer and winter holiday shutdowns, generous paid time off, and holiday policies.
• Enhanced parental leave and life/AD&D insurance benefits.
• Daily subsidized lunch when working onsite.