Director, Regulatory Affairs (Infectious Disease)

TL;DR

Director, Regulatory Affairs (Infectious Disease): Serving as the primary Regulatory Lead for infectious disease biologics programs with an accent on global regulatory strategy, IND submissions, and health authority interactions. Focus on driving cross-functional development from early stages through clinical trials while ensuring compliance with FDA and global standards.

Location: Must be based in the U.S. (Remote or hybrid in Berkeley Heights, NJ).

Salary: $150,000 - $240,000 USD.

Company

hirify.global is a fully integrated, commercial-stage biotechnology company focused on developing treatments for CNS and immunology conditions.

What you will do

• Serve as the primary Regulatory Lead for infectious disease biologics programs.
• Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
• Lead the preparation and coordination of regulatory submissions, including pre-IND packages and INDs.
• Direct interactions with the FDA and other health authorities, managing queries and briefing documents.
• Partner with cross-functional teams including nonclinical, CMC, and clinical departments.
• Assess regulatory risks and communicate mitigation recommendations to senior leadership.

Requirements

• 10–12+ years of progressively responsible regulatory experience.
• Must be authorized to work in the U.S. (no sponsorship provided).
• Strong scientific foundation in immunology, infectious diseases, or related biological disciplines.
• Proven experience preparing and submitting INDs and early-phase regulatory documents.
• Deep knowledge of FDA, ICH, and global regulatory guidelines.
• Ability to travel up to 20%.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401k retirement savings plan with company match.
• Annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Career development and training opportunities.